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The efficacy of basal insulin (BI) for adequate glycemic control in patients with type 2 diabetes mellitus (T2DM) has been well documented by randomized clinical trials. This post hoc analysis of the Observational Registry of Basal Insulin Treatment (ORBIT) study was performed to explore the 6-month dose of BI used in insulin-naïve T2DM patients achieving HbA1c target (7%) and determine the patient characteristics that affect the 6-month dose of BI in the setting of real-world clinics in China.This multicenter observational registry screened 19 894 adult T2DM patients with inadequately controlled hyperglycemia and treated with oral antidiabetic drugs (OADs) in China. Of these patients, 5191 who continued to receive BI after 6 months and achieved HbA1c target were analyzed. Patient characteristics including age, body weight, fasting plasma glucose (FPG), use of OADs, insulin (type and dose), and glycemic control were recorded at baseline and 6-month follow-ups.The 6-month dose of BI needed for effective glycemic control was 0.20 ± 0.08 U/kg/day. High body mass index, high FPG, young age, longer duration of diabetes or OAD treatment, a greater number of OADs at baseline, and allocation to detemir and glargine were significant independent predictors for high dose of BI at 6 months.This post hoc analysis of the ORBIT registry provides key information on the 6-month dose of BI needed for effective glycemic control in Chinese T2DM patients. Furthermore, it identified crucial patient characteristics that are significant determinants of the dose of BI in a real-world setting.背景: 基础胰岛素(BI)对2型糖尿病(T2DM)患者血糖控制的有效性已被随机对照临床试验所证实。这项来自ORBIT研究的事后分析旨在探讨既往未接受胰岛素治疗的中国T2DM患者, 在临床真实世界中接受基础胰岛素治疗6个月后, HbA1c达标(7%)患者的基础胰岛素剂量及其相关特征。 方法: ORBIT研究在中国采用多中心观察性研究方法, 共筛选入组19894例接受口服降糖药(OAD)治疗但血糖控制不佳的2型糖尿病患者。本研究对其中5191例持续接受BI治疗6个月且HbA1c达标(7%)的患者进行了分析。收集的患者特征包括基线和随访6个月时的年龄, 体重, 空腹血浆血糖(FPG), OAD使用情况, 胰岛素的类型和剂量以及血糖控制情况。 结果: 治疗6个月时血糖达标患者的BI剂量为0.20±0.08U/kg/d。高体重指数, 高FPG, 年龄小, 糖尿病病程或OAD治疗时间较长, 基线OAD种类多, 接受地特胰岛素或甘精胰岛素治疗是6个月时较高BI剂量的独立预测因素。 结论: 这项ORBIT研究的事后分析提供了启动基础胰岛素治疗6个月的中国2型糖尿病患者血糖控制达标所需BI剂量的关键信息。此外, 该研究明确了在临床真实世界中影响基础胰岛素剂量的患者特征。.

Background: Acute lung injury (ALI) is a severe life-threatening inflammatory disease. Neutrophil activation is a major pathogenic factor in ALI. Protein kinase B (PKB)/AKT regulates diverse cellular responses, but the significance in neutrophilic inflammation and ALI remains unknown. Methods: Human neutrophils and neutrophil-like differentiated HL-60 (dHL-60) cells were used to examine the anti-inflammatory effects of 5,7-dimethoxy-1,4-phenanthrenequinone (CLLV-1). The therapeutic potential of CLLV-1 was determined in a mouse model of lipopolysaccharide (LPS)-induced ALI. Findings: CLLV-1 inhibited respiratory burst, degranulation, adhesion, and chemotaxis in human neutrophils and dHL-60 cells. CLLV-1 inhibited the phosphorylation of AKT (Thr308 and Ser473), but not of ERK, JNK, or p38. Furthermore, CLLV-1 blocked AKT activity and covalently reacted with AKT Cys310 in vitro. The AKT309-313 peptide-CLLV-1 adducts were determined by NMR or mass spectrometry assay. The alkylation agent-conjugated AKT (reduced form) level was also inhibited by CLLV-1. Significantly, CLLV-1 ameliorated LPS-induced ALI, neutrophil infiltration, and AKT activation in mice. Interpretation: Our results identify CLLV-1 as a covalent allosteric AKT inhibitor by targeting AKT Cys310. CLLV-1 shows potent anti-inflammatory activity in human neutrophils and LPS-induced mouse ALI. Our findings provide a mechanistic framework for redox modification of AKT that may serve as a novel pharmacological target to alleviate neutrophilic inflammation. Funding Statement: This research was financial supported by the grants from the Ministry of Science Technology (MOST 106-2320-B-255-003-MY3 and MOST 104-2320-B-255-004-MY3), Ministry of Education (EMRPD1G0231 and EMRPD1H0381), and Chang Gung Memorial Hospital (CMRPF1F0011~3, CMRPF1F0061~3, CMRPF1G0241~3, and BMRP450), Taiwan. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Declaration of Interests: The authors declare that no competing interests exist. Ethics Approval Statement: The procedure of neutrophil isolation was approved by the Institutional Review Board at Chang Gung Memorial Hospital. ALI was induced by intra-tracheal spray of 2 mg/kg LPS (Escherichia coli 0111:B4) in seven to eight weeks old C57BL/6 male mice, according to the guidelines and approved by Institutional Animal Care and Use Committee of Chang Gung University, Taiwan.

Industrial Design History is a basic course in industrial design college. It allows design students to develop products with greater insight as it relates to the historical perspective of the users. In Industrial Design History courses, teachers’ research methods in combination with new-generation designers and designers throughout history will achieve this goal. Despite the prevalence of industrial design history knowledge, there is still a lack of studies which address industrial design history education, which needs to be reflected upon. In this way, industrial design history teaching methods can be integrated into design education and practice. The purpose of this study is to show a case study in industrial design history teaching method “from styling perception to styling creation”. In the past 15 years, there has been considerable development of critical literature about design. Journals such as Design Issues, The Journal of Design History, etc., have demonstrated that design is a subject that can sustain critical discourse just as well as art, architecture, or literature. The conclusion includes a summary of key findings on the teaching of industrial design history. The significance of this case study is to further research into teaching methods of Industrial Design History as well as providing a common frame for the course.

Background Limited information exists on the efficacy of pregabalin in Chinese patients with diabetic peripheral neuropathy (pDPN). Methods An 11-week, double-blind, placebo-controlled trial in Chinese pDPN patients randomized (1:1) to pregabalin 300 mg/day or placebo. Primary efficacy endpoint was change from baseline in mean daily pain score (0 = no pain;10 = worst possible pain). Secondary efficacy endpoints included overall weekly mean pain score, responder status, impression of change, pain intensity, and sleep. Subgroup analysis assessed change in pain in patients with severe (≥7) baseline pain. Adverse events (AEs) were reported. ClinicalTrials.gov Identifier:NCT01332149. Results In total, 620 patients were randomized and treated (313, pregabalin; 307, placebo). Improvement in mean pain score with pregabalin versus placebo was not significant (mean treatment difference –0.28;P=0.0559). Post-hoc sensitivity analyses, excluding one patient due to GCP non-compliance, showed pregabalin significantly improved mean pain score when excluding the patient (–0.30;P=0.0448) or the associated site (–0.38;P=0.0142). Pregabalin significantly improved overall weekly mean pain score (P=0.0164) and ≥50% responders at endpoint (P=0.0384). Improvement in ≥30% responders, impression of change, pain intensity, and sleep were not significant. In the severe subpopulation, pregabalin significantly improved mean pain score versus placebo (–0.79;P=0.0040). The most commonly reported AE was dizziness (9.6% vs 3.9% with placebo). Conclusions Pregabalin did not significantly improve the primary measure of pain. Significant reductions in mean pain score were observed when excluding the GCP–non-compliant patient or site and in the severe subpopulation. Pregabalin was well tolerated in Chinese pDPN patients.

Aims: To compare glucose control and safety of different basal insulin therapies (BI, including Insulin NPH, glargine and detemir) in real-world clinical settings based on a large-scale registry study.Methods: In this multi-center 6-month prospective observational study, patients with type 2 diabetes (HbA1c >= 7%) who were uncontrolled by oral anti-diabetic drugs (OADs) and were willing to initiate BI therapy were enrolled from 209 hospitals within 8 regions of China. Type and dose of BI were at the physician's discretion and the patients' willingness. Interviews were conducted at 0 months (visit 1), 3 months (visit 2) and 6 months (visit 3). Outcomes included change in HbA1c, hypoglycemia rate and body weight from baseline at 6 months.Results: A total of 16 341 and 9002 subjects were involved in Intention-To-Treat (ITT) and per-protocol (PP) analysis, respectively. After PS regression adjustment, ITT analysis showed that reduction in HbA1c in glargine (2.2% +/- 2.1%) and detemir groups (2.2% +/- 2.1%) was higher than that in the NPH group (2.0% +/- 2.2%) (P < .01). The detemir group had the lowest weight gain (-0.1 +/- 2.9 kg) compared with the glargine (+0.1 +/- 3.0 kg) and NPH (+0.3 +/- 3.1 kg) groups (P < .05). The glargine group had the lowest rate of minor hypoglycaemia, while there was no difference in severe hypoglycaemia among the 3 groups. The results observed in PP analyses were consistent with those in ITT analysis.Conclusion: In a real-world clinical setting in China, treatment with long-acting insulin analogues was associated with better glycaemic control, as well as less hypoglycaemia and weight gain than treatment with NPH insulin in type 2 diabetes patients. However, the clinical relevance of these observations must be interpreted with caution.

To examine treatment patterns following basal insulin (BI) introduction in type 2 diabetes mellitus (T2DM) patients under real-world conditions across China.Overall, 18 995 patients inadequately controlled (HbA1c ≥ 53 mmol/mol [7%]) with oral antihyperglycaemic drugs (OADs) and willing to receive BI treatment were registered at 209 hospitals and followed at baseline (visit 1), 3 months (visit 2) and 6 months (visit 3). Type of BI was initiated at physicians' discretion.Retention with BI therapy at 6 months was 75.6%. Use of long-acting BI predominated, with insulin glargine accounting for 71%, detemir 13% and Neutral Protamine Hagedorn (NPH) insulin 16%. Over 70% of long-acting users maintained the same initial BI at visit 3, while 40% of NPH users switched treatment and 24.4% of participants initiated BI with prandial insulin. The initial mean (± SD) dose of BI and total insulin was 0.18 ± 0.07 and 0.25 ± 0.19 IU/kg, respectively, with a mean increase of daily dose by 0.03 and 0.02 IU/kg after 6 months, respectively. Only 56.6% of insulin users reported dose titration at visit 3. Mean HbA1c was 81 mmol/mol (9.6%) at baseline and 57 mmol/mol (7.4%) at 6 months. The frequency of hypoglycaemia was 1.61 and 2.07 episodes/patient-year at baseline and 6 months, respectively.In real-world clinical settings, add-on BI therapy in T2DM patients is associated with significant improvement in glycaemic control without overtly compromising safety related to hypoglycaemia and weight gain. Evolution of insulin treatment regimens varied among patients, but dose titration was suboptimal. More active BI dose titration might further improve glycaemic outcome in patients receiving BI therapy.A free Video Abstract to accompany this article is available at https://vimeo.com/212655959.

Nationwide data on glycemic control, blood pressure (BP) control and lipid control in patients with newly diagnosed type 2 diabetes were vacant in China. The aim of this study was to assess the clinical outcomes for these patients. This is an observational prospective cohort study with 12 months of follow up. Patients with a diagnosis of type 2 diabetes less than 6 months were enrolled. Hemoglobin A1c (HbA1c) levels, BP levels and lipid levels were collected at baseline and the follow-ups. This study was registered at www.clinicaltrials.gov (NCT01525693). A total of 5770 participants from 79 hospitals across six geographic regions of China were recruited. After 12 months of treatment, 68.5% of these patients achieved HbA1c

Background Type 2 diabetes mellitus (T2DM) is a significant burden in China, where approximately 114 million patients have been diagnosed with diabetes. Chinese patients present with prominent β-cell failure, with resulting deficiency in insulin secretion, particularly early phase insulin secretion leading to postprandial hyperglycemia. Sitagliptin, a selective once-daily oral dipeptidyl peptidase-4 inhibitor, has been shown to improve glycemic control as monotherapy and in combination with other antihyperglycemic agents, including sulfonylureas and metformin. Methods This was a multicenter randomized double-blind placebo-controlled study conducted in China. The study assessed the safety and efficacy of the addition of sitagliptin 100 mg once daily versus placebo on changes from baseline at Week 24 in HbA1c, fasting plasma glucose (FPG) and 2-h post-meal glucose (PMG). Patients were aged 18–79 years, had T2DM with inadequate glycemic control, and were taking a sulfonylurea, with or without metformin. Results After 24 weeks, sitagliptin reduced HbA1c, FPG, and 2-h PMG significantly more than placebo (between-treatment differences: −0.61 %, −16.8 mg/dL, and −32.9 mg/dL, respectively; P

Background This study determined the efficacy and safety of once-daily oral alogliptin in patients from mainland China, Taiwan, and Hong Kong with type 2 diabetes mellitus. Methods In this Phase 3 multicenter double-blind placebo-controlled 16-week trial, 506 patients were randomized to receive once-daily alogliptin 25 mg or placebo: 185 in the monotherapy group, 197 in the add-on to metformin group, and 124 in the add-on to pioglitazone group. The primary efficacy variable was the change from baseline (CFB) in HbA1c at Week 16; other efficacy measures included CFB to Week 16 in fasting plasma glucose (FPG), incidence of marked hyperglycemia (FPG ≥11.1 mmol/L), and the incidence of clinical HbA1c ≤6.5 % (48 mmol/mol) and ≤7.0 % (53 mmol/mol) at Week 16. Safety was assessed throughout the trial. Results Alogliptin monotherapy provided a significantly greater decrease in HbA1c from baseline to Week 16 compared with placebo (−0.58 %; 95 % confidence interval [CI] –0.78 %, −0.37 %; P

Introduction To lower the barrier for initiating insulin treatment and obtain adequate glycemic control in type 2 diabetes mellitus (T2DM), new basal insulin preparations with improved pharmacological properties and consequently a lower risk of hypoglycemia are needed. The objective of this trial was to confirm the efficacy and compare the safety of insulin degludec (IDeg) with insulin glargine (IGlar) in a multinational setting with two thirds of subjects enrolled in China. Methods This was a 26-week, randomized, open-label, parallel-group, treat-to-target, non-inferiority trial in 833 subjects with T2DM (48 % were female, mean age 56 years, diabetes duration 8 years), inadequately controlled on oral antidiabetic drugs (OADs). Subjects were randomized 2:1 to once-daily IDeg (555 subjects) or IGlar (278 subjects), both with metformin. The primary endpoint was the change from baseline in glycosylated hemoglobin (HbA1c) after 26 weeks. Results The completion rate was high (IDeg 94.2 %; IGlar 91.4 %). Mean HbA1c decreased from 8.3 to 7.0 % in both groups. Estimated treatment difference (ETD) [95 % confidence interval (CI)] IDeg-IGlar in change from baseline was −0.05 % points [−0.18 to 0.08], confirming the non-inferiority of IDeg to IGlar. The proportion of subjects achieving HbA1c

The age of onset of type 2 diabetes is decreasing. Because non-Chinese patients with early-onset type 2 diabetes (defined here as diagnosis at40 years) have increased risk of vascular complications, we investigated effects of early-onset versus late-onset type 2 diabetes on risk of non-fatal cardiovascular diseases in China.We did a cross-sectional survey using data from the China National HbA1c Surveillance System (CNHSS), including 222,773 Chinese patients with type 2 diabetes in 630 hospitals from 106 cities in 30 provinces of China in 2012. We documented demographic information and clinical profiles. Non-fatal cardiovascular disease was defined as non-fatal coronary heart disease or non-fatal stroke. Prevalence of non-fatal cardiovascular diseases was standardised to the Chinese population in 2011. We did logistic regression analysis to obtain odds ratios (ORs) for the risk of cardiovascular disease in patients with early-onset versus late-onset type 2 diabetes. Because the CNHSS did not contain patients on diet or lifestyle treatment alone, and did not capture information on smoking or lipid or antihypertensive treatment, we validated our findings in another dataset from a cross-sectional, multicentre observational study (the 3B study) of outpatients with type 2 diabetes to confirm that exclusion of patients with diet treatment only and non-adjustment for lipid-lowering and antihypertensive drugs did not introduce major biases in the main analysis.Of 222,773 patients recruited from April 1, 2012, to June 30, 2012, 24,316 (11%) had non-fatal cardiovascular disease. Patients with early-onset diabetes had a higher age-adjusted prevalence of non-fatal cardiovascular disease than did patients with late-onset diabetes (11·1% vs 4·9%; p0·0001). After adjustment for age and sex, patients with early-onset type 2 diabetes had higher risk of non-fatal cardiovascular disease than did those with late-onset type 2 diabetes (OR 1·91, 95% CI 1·81-2·02). Adjustment for duration of diabetes greatly attenuated the effect size for risk of non-fatal cardiovascular disease (1·13, 1·06-1·20). Results of the validation study showed that exclusion of patients with diet only and non-adjustment for lipid-lowering and antihypertensive drugs resulted in marginal changes in ORs for risk of non-fatal cardiovascular disease in patients with early-onset versus late-onset type 2 diabetes. Early-onset type 2 diabetes remained associated with increased risk of cardiovascular disease, attributable to longer duration of diabetes.Chinese patients with early-onset type 2 diabetes are at increased risk of non-fatal cardiovascular disease, mostly attributable to longer duration of diabetes.Novo Nordisk China (for the China National HbA1c Surveillance System [CNHSS]) and Merck SharpDohme China (for the 3B study).

Efficacy of basal insulin (BI) has been well studied by randomized controlled trials, but the impact of BI on glycemic control in the real world has not been well documented. The Observational Registry for BI Treatment (ORBIT) study is designed to evaluate the real-life outcomes of BI in China.Participants with type 2 diabetes (n=19,894), from December 2011 to June 2013, inadequately controlled on oral hypoglycemic agents (OHAs) were initiated on BI treatment from 209 hospitals in all the eight regions in Mainland China. Data for each patient on use of OHAs and insulin (type and dose), glycemic control, hypoglycemic episodes, body weight, quality of life, and costs were collected at baseline and 3 and 6 months.For the 18,995 participants who were eligible for baseline analysis, mean±SD age was 55.4±10.4 years, with 52.5% males. The mean duration of diabetes was 6.4±5.3 years and was positively associated with the economic level of eight regions. Before initiation of BI, patients had a mean hemoglobin A1c level of 9.6±2.0% with a fasting plasma glucose level of 11.7±4.0 mmol/L. Of the patients, 35.5% had some diabetes complications. Metformin, sulfonylureas, and α-glycosidase inhibitors were the most commonly used OHAs. The proportions of patients using one, two, or more than two OHAs before BI initiation were 48.4%, 42.7%, and 8.9%, respectively.To the best of our knowledge, the ORBIT study is the largest registry study to evaluate glycemic outcomes and safety of BI in real-world China. Baseline data indicate delays in initiation of BI in the majority of patients with type 2 diabetes in China.

Self-adjustment of insulin dose is commonly practiced in Western patients with type 2 diabetes but is usually not performed in Asian patients. This multinational, 24-week, randomized study compared patient-led with physician-led titration of once-daily insulin glargine in Asian patients with uncontrolled type 2 diabetes who were on 2 oral glucose-lowering agents.Patient-led (n = 275) or physician-led (n = 277) subjects followed the same dose-titration algorithm guided by self-monitored fasting blood glucose (FBG; target, 110 mg/dL [6.1 mmol/L]). The primary endpoint was change in mean glycated hemoglobin (HbA1c) at week 24 in the patient-led versus physician-led titration groups.Patient-led titration resulted in a significantly higher drop in HbA1c value at 24 weeks when compared with physician-led titration (-1.40% vs. -1.25%; mean difference, -0.15; 95% confidence interval, -0.29 to 0.00; P = .043). Mean decrease in FBG was greatest in the patient-led group (-2.85 mmol/L vs. -2.48 mmol/L; P = .001). The improvements in HbA1c and FBG were consistent across countries, with similar improvements in treatment satisfaction in both groups. Mean daily insulin dose was higher in the patient-led group (28.9 units vs. 22.2 units; P.001). Target HbA1c of7.0% without severe hypoglycemia was achieved in 40.0% and 32.9% in the patient-led and physician-led groups, respectively (P = .086). Severe hypoglycemia was not different in the 2 groups (0.7%), with an increase in nocturnal and symptomatic hypoglycemia in the patient-led arm.Patient-led insulin glargine titration achieved near-target blood glucose levels in Asian patients with uncontrolled type 2 diabetes who were on 2 oral glucose-lowering drugs, demonstrating that Asian patients can self-uptitrate insulin dose effectively when guided.

Background The aim of the present study was to assess the relationship between night sleep duration and glycemic and triglyceride (TG) levels among people with different glycemic status. Methods In all, 18 121 subjects aged ≥40 years were enrolled in this cross-sectional study, including 4318 with impaired glucose regulation (IGR), 4225 with diabetes, and 9578 with normal glucose regulation (NGR). The IGR + diabetes and NGR groups were divided into three subgroups according to self-reported night sleep duration as follows: (i) 9 h. The associations of sleep duration with HbA1c, fasting plasma glucose (FPG), 2-h post-load plasma glucose (PPG), and TG levels were examined. Results Long night sleep duration (>9 h) was associated with higher HbA1c, FPG, PPG, and TG levels compared with sleep duration of 6–9 h (P 9小时）的患者具有较高的HbA1c、FPG、PPG和TG水平（P值均

Background This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea. Methods In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo. The primary endpoint was absolute change in glycated haemoglobin (HbA1c) from baseline to week 24. Results A total of 391 patients were randomized. Lixisenatide significantly reduced HbA1c levels compared with placebo (LS mean difference: −0.36%, p = 0.0004). A significantly higher proportion of lixisenatide-treated patients achieved HbA1c targets of

The ACE trial is examining whether acarbose, an insulin-sparing postprandial glucose-lowering agent, can reduce cardiovascular (CV) events in patients who have coronary heart disease (CHD) and impaired glucose tolerance (IGT), with prevention of type 2 diabetes (T2D) as a secondary outcome.1., 2. This update report evaluates the impact of the protocol-driven 4-week CV risk management optimization strategy during the run-in period, lists participant baseline characteristics, and examines whether temporal differences occurred during the 7-year recruitment period.

Background The present subanalysis of the Study of Once Daily Levemir (SOLVE) study was to evaluate the safety and efficacy of once-daily insulin detemir as add-on to oral antidiabetic drugs (OADs) in Chinese type 2 diabetes patients according to body mass index in a real-life setting. Methods In all, 3272 eligible patients who were treated with diet, exercise, and one or more OAD were prescribed once-daily insulin detemir by their physician according to routine clinical practice and were followed-up for 24 weeks. The incidence of serious adverse reactions (SADRs), including major hypoglycemia, was the primary endpoint. Subanalyses were performed on patients in the following BMI groups: normal weight (BMI

Background Low socioeconomic status (SES) is associated with adverse cardiovascular risk factor patterns and poor outcomes in patients with diabetes. The aim of this study was to determine whether SES is associated with the control of blood glucose, blood pressure, blood cholesterol (3Bs), and diabetic complications in Chinese adults with type 2 diabetes. Methods Data regarding patients’ demographics, social economics, diabetes complications, and cardiovascular risk profiles were analyzed for 25,454 patients. The outcomes of interest were the proportions of patients with HbA1c

To assess efficacy/safety of initial linagliptin/metformin single-pill combination (SPC) therapies versus individual drug components over 24weeks in treatment-naïve Asian patients with type 2 diabetes mellitus and insufficient glycemic control.Patients (initial glycated hemoglobin [HbA1c] ⩾7.5% to11.0% [58-97mmol/mol]; main group) were randomized to: linagliptin 5mg once daily (qd); metformin 500mg twice daily (bid); metformin 1000mg bid; linagliptin 2.5mg/metformin 500mg bid; or linagliptin 2.5mg/metformin 1000mg bid. Patients with severe hyperglycemia (HbA1c ⩾11.0% [97mmol/mol]) received linagliptin 2.5mg/metformin 1000mg bid or linagliptin 5mg qd (switched at week 12 from linagliptin to SPC if HbA1c8.0% [64mmol/mol]). The main group primary endpoint was HbA1c change from baseline to week 24.At week 24, adjusted mean change from baseline in HbA1c (main group, n=733) was: linagliptin 5mg qd, -1.3%; metformin 500mg bid, -1.6%; metformin 1000mg bid, -2.1%; linagliptin 2.5mg/metformin 500mg bid, -2.2%; linagliptin 2.5mg/metformin 1000mg bid, -2.3%. The first test of primary HbA1c analysis (linagliptin 2.5mg/metformin 1000mg bid vs. metformin 1000mg bid) was borderline non-significant; however, SPCs produced significantly greater reductions in HbA1c from baseline versus respective monotherapies in all but one pre-defined sensitivity analysis. In the severe hyperglycemia group (n=143), linagliptin 2.5mg/metformin 1000mg bid produced a superior HbA1c reduction (-4.7%) versus linagliptin 5mg qd (-3.5%) after 12weeks. Hypoglycemic adverse events were low across groups.Initial linagliptin/metformin SPC significantly improved glycemic control in this population.

Aims To compare the efficacy and safety of combination of vildagliptin and metformin therapy with metformin uptitration in Chinese patients with type 2 diabetes (T2DM) inadequately controlled with low-dose metformin. Methods In this 24-week prospective, randomized, multicentre, open-label study, patients with T2DM inadequately controlled with metformin ≤1000 mg daily were divided 1 : 1 : 1 : 1 into four prespecified subgroups based on age and body mass index (BMI). Patients in each subgroup were randomized 5 : 1 to receive either vildagliptin (50 mg twice daily) plus metformin [500 mg twice daily; vildagliptin and low-dose metformin (VLDM) group] or metformin uptitration [1000 mg twice daily; high-dose metformin (HDM) group]. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline at week 24. The key secondary endpoints included percentage of patients achieving target HbA1c without adverse gastrointestinal (GI) events and mean change in fasting plasma glucose (FPG) from baseline to week 24. Results A total of 3084 patients were randomized. HbA1c reduction of 0.54% at week 24 in the VLDM group was non-inferior and statistically superior compared with 0.40% in the HDM group (P < 0.0001). VLDM's non-inferiority to HDM was confirmed in the four subgroups and its superiority was shown for all subgroups (p < 0.05) except for the subgroup of patients aged

Summary Objective To investigate the effect of healthcare provider (HCP) type (primary vs. specialist) on glycaemic control and other treatment parameters. Research design and methods Study of Once-Daily Levemir (SOLVE™) is an international, 24-week, observational study of insulin initiation in people with type 2 diabetes. Results A total of 17,374 subjects were included, comprising 4144 (23.9%) primary care subjects. Glycaemic control improved in both HCP groups from baseline to final visit [glycated haemoglobin (HbA1c) −1.2 ± 1.4% (−13.1 ± 15.3 mmol/mol) and −1.3 ± 1.6% (−14.2 ± 17.5 mmol/mol), respectively]. After adjustment for known confounders, there was no statistically significant effect of HCP group on final HbA1c [−0.04%, 95% confidence interval (CI) −0.09 to −0.01 (−0.4 mmol/mol, 95% CI −1.0−0.1 mmol/mol), p = 0.1590]. However, insulin doses at the final visit were higher in primary care patients (+0.06, 95% CI 0.06–0.07 U/kg, p < 0.0001). Logistic regression demonstrated a significant effect of HCP type (primary vs. specialist care) on hypoglycaemia risk [odds ratio (OR) 0.75, 95% CI 0.64–0.87, p = 0.0002]. Primary care physicians took more time to train patients and had more frequent contact with patients than specialists (both p < 0.0001). Conclusions Primary care physicians and specialists achieved comparable improvements in glycaemic control following insulin initiation.

Diabet. Med. 29, 515–521 (2012) Abstract Aim To describe the status of glycaemic control, self-reported adherence to treatments, psychological well-being and quality of life in Chinese patients with Type 2 diabetes in 2006. Methods Subjects having registered for care for > 12 months at a diabetes clinic were enrolled in this study. Glycaemic control was determined by HbA1c and plasma glucose levels; information about self-reported adherence to treatments was obtained by questionnaire; psychological well-being was assessed by use of a modified World Health Organization-5 Well-being Index; and quality of life was measured by use of a modified Diabetes Attitudes, Wishes and Needs (DAWN) survey. All data were tabulated and statistical analyses were performed. Results A total of 2702 patients were enrolled during 2006. Only 23% of patients achieved an HbA1c level of

Background Few studies have assessed the use of new oral anti-diabetic agents in Asian populations. This study assesses the efficacy and safety of saxagliptin versus placebo in Asian patients with type 2 diabetes mellitus (T2DM). Materials and Methods Five hundred sixty-eight drug-naive adult patients with T2DM and glycated haemoglobin levels (HbA1c) of 7.0–10.0% (53–86 mmol/mol) were randomized 1 : 1 to receive saxagliptin 5 mg daily or placebo. Efficacy endpoints included changes from baseline to week 24 in HbA1c, fasting plasma glucose (FPG), post-prandial glucose area under the curve from 0 to 180 min (PPG AUC0–180), and the proportion of patients achieving HbA1c

We describe an elderly male patient who presented with fever of unknown origin and refractory hyponatraemia. Following (18) fluorine-fluorodeoxyglucose positron emission tomography/computed tomography scan and core adrenal biopsy, the diagnosis of diffuse large B-cell non-Hodgkin lymphoma with pituitary and bilateral adrenal involvement was confirmed. After chemotherapy, his symptoms resolved, and all the lesions shrank significantly.

Aim To assess efficacy and safety of saxagliptin added to metformin versus placebo plus metformin in Asian patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin alone. Methods Adults (HbA 1c 7.0–10.0%, on stable metformin ≥1500mg/day) were randomized 1:1 to saxagliptin 5mg daily plus metformin ( n =283) or placebo plus metformin ( n =287). The primary end point was HbA 1c change from baseline to Week 24. Results Saxagliptin plus metformin provided significant adjusted mean decreases versus placebo plus metformin ( p ≤0.0052) in HbA 1c (−0.78% versus −0.37%), fasting plasma glucose (−1.14mmol/L versus −0.58mmol/L), and postprandial glucose area under the curve from 0 to 180min (−315mmolmin/L versus −160mmolmin/L). Significantly more saxagliptin-treated patients achieved a therapeutic glycemic response (HbA 1c p =0.0001). The proportion of patients experiencing adverse events (excluding hypoglycemia) was similar for saxagliptin plus metformin (42.8%) versus placebo plus metformin (40.8%). Hypoglycemic events were reported in 1.4% of patients in each group. Conclusion Saxagliptin added to metformin significantly improved glycemic control and was well tolerated in Asian patients with T2DM who had inadequate glycemic control with metformin and diet and lifestyle modification.

Approximately 77 million persons with diabetes reside in the Western Pacific Region. This number is estimated to rise to 113 million in 2030 with increasing burden of cardio-renal disease, affecting an increasingly young population. Randomized clinical trials have confirmed the benefits of using statins to reduce low-density lipoprotein cholesterol in preventing cardiovascular disease (CVD) in Caucasians, although similar data are lacking in Asia. Experts from the Western Pacific Region met and reviewed evidence regarding risk association of diabetic dyslipidaemia with cardio-renal disease, effects of lipid lowering, recommended guidelines and clinical practices in Asian populations. There is strong evidence supporting the role of diabetic dyslipidaemia in cardio-renal disease and the benefits of lipid lowering in these populations. The high rate of diabetic kidney disease, its close links with CVD, and the benefits of lipid lowering on renal function are particularly relevant to this population. While most national guidelines use criteria similar to the West in management of diabetic dyslipidaemia, there are consistently low rates of use of lipid-lowering drugs and attaining treatment goals in the region. The group recommends conducting randomized studies, strengthening of the health care system to promote early detection, and intervention of diabetic dyslipidaemia to prevent end organ damage.

This study is aimed at developing and evaluating a diabetes risk score (DRS) to predict incident diabetes and screen for undiagnosed diabetes and abnormal glucose tolerance in the Chinese population.Three DRS instruments were respectively developed and validated based on the data collected from a 10-year longitudinal health checkup-based population of 1,851 individuals without diabetes at baseline. The efficiency on glucose abnormality screening was evaluated based on the testing of a cross-sectional sample of 699 individuals without known diabetes.The DRS consisting of age, hypertension, history of high blood glucose, body mass index, fasting plasma glucose, serum triglycerides, and serum high-density lipoprotein-cholesterol had the best prediction properties (area under curve [AUC] = 0.734 [95% confidence interval 0.702-0.766] and 0.759 [0.686-0.831] in exploratory and validation cohorts, respectively). The DRS had a sensitivity of 64.5% and 72.9%, respectively, and a specificity of 71.6% and 63.9%, respectively, with an optimal cutoff of 4. AUCs were 0.828 (0.797-0.860) and 0.909 (0.884-0.933) for detecting abnormal glucose tolerance and diabetes, respectively, through cross-sectional screening. Performance of the oral glucose tolerance test (OGTT) in selected subjects with DRS ≥ 4 led to the identification of 76.2% cases of abnormal glucose tolerance and 100% cases of diabetes, while avoiding an OGTT in 52.8% of the study group.The DRS instrument including age, hypertension, history of high blood glucose, body mass index, fasting plasma glucose, triglycerides, and high-density lipoprotein-cholesterol is practical and effective in predicting incident diabetes and screening glucose abnormality in the Chinese population.

The purpose of this study was to evaluate the direct medical costs of type 2 diabetes mellitus with or without complications, and to determine the economic impact of complications on type 2 diabetic patients.We performed a cross-sectional study of prevalent type 2 diabetes carried out in four major cities of China. The study populations were 1530 outpatients and 524 inpatients from clinics or wards of a total of 20 hospitals, using a two-phase subject enrollment process, by face-to-face interview with a unique questionnaire.The annual direct medical cost per patient was estimated to be 4800 Chinese Yuan (CNY) in median or 10,164 CNY in mean. There is a difference between annual direct medical costs for patients with or without complications (6056 vs. 3583 CNY; P0.001). It is also significantly different for the pay-out-of-pocket proportions (P = 0.015) between the patients with (44.6%) and without complications (40.4%). The direct medical cost varied significantly among the four cities (P0.001). Patients who simultaneously suffered microvascular and macrovascular diseases had higher direct medical cost (7600) than those with macrovascular (6000) (P = 0.012) and microvascular disease (5364) (P0.001), and those without both (3600) (P0.001). The correlation was statistically significant between the number of complications and direct medical costs (P0.001).The high economic burden raised by diabetes and its complications challenges the Chinese health-care system. It implicates an urgent need of intervention to prevent the development of long-term complications among the diabetic population, especially on the development of complications in high-cost body system.

To describe and compare the differences in subject characteristics, glycaemic control, diabetes complications, and treatment between 1998 and 2006 in patients with type 2 diabetes.Subjects who had been registered for diabetes care at the diabetes clinic (defined as any clinic treating over 100 patients/month) for over 12 months were enrolled. The data were retrospectively reviewed, including diabetes history, treatment regimens and laboratory assessments. HbA1c was measured at a central laboratory. All data were tabulated and statistical analyses were performed.The Diabcare studies included 2246 subjects (mean age: 59.7 years) in 1998 and 2702 subjects (mean age: 61.9 years) in 2006. The mean duration of diabetes was 8.2 years in 1998 and 8.7 years in 2006 and mean BMI was 23.8 kg/m2 in 1998 and 24.6 kg/m2 in 2006. The mean glycaemic control improved significantly from 1998 (8.7 +/- 2.0%) to 2006 (7.6 +/- 1.6%) and significantly more patients reached HbA(1c)7% oror = 6.5% in 2006. The mean fasting plasma glucose (FPG) values were 9.0 +/- 3.4 mmol/L in 1998 and 7.7 +/- 2.5 mmol/L in 2006. From 1998 to 2006, cataract, neuropathy and background retinopathy remained the most frequently observed diabetes complications. The percentage of the subjects treated with oral antidiabetic drugs (OADs) alone decreased from approximately 75% in 1998 to approximately 50% in 2006, while the proportion of patients on insulin only and on OADs in combination with insulin was greater in 2006 than 1998. The majority of subjects rated their quality of life as good or acceptable in 2006.Glycaemic control, diabetes therapy and patient care were improved in 2006. However, the gap between therapeutic guidelines and glycaemic control strongly suggests that promoting awareness of treat-to-target treatment and continuing medical education in clinical practice are still needed.

Objective: This open, prospective, non-interventional, non-randomised, multicentre postmarketing surveillance study was conducted over a mean period of 13.9 weeks to assess the efficacy, safety and acceptance of acarbose in Chinese patients with type 2 diabetes mellitus and subjects with impaired glucose tolerance (IGT) in routine clinical practice. Subjects with IGT were included in analyses because acarbose has been approved for treatment of this condition since 2002. Patients and methods: A total of 2550 study participants were enrolled by 133 physicians throughout China. Efficacy parameters were the changes from initial visit to the end of study in glycosylated haemoglobin (HbA1c), fasting blood glucose (FBG), postprandial BG and bodyweight. Results: The majority of study participants (74.7%) were newly diagnosed. Most (77.0%) were administered acarbose 50mg three times daily (the recommended standard dose in China) throughout the study and more than half (51.7%) received concomitant antihyperglycaemic treatment. Acarbose treatment reduced HbA1c by 1.4% to 6.7%, FBG by 38.5 mg/dL to 116.4 mg/dL, 2-hour postprandial BG by 92.2 mg/dL to 149.0 mg/dL and bodyweight by 0.4kg to 67.5kg. Subgroup analyses for type 2 diabetes and IGT populations were also conducted. In diabetic patients, HbA1c was reduced by 1.4%, FBG by 42.1 mg/dL and 2-hour postprandial BG by 98.9 mg/dL. Marked reductions were also achieved in the IGT population (0.9% for HbA1c, 11.8 mg/dL for FBG and 42.9 mg/dL for 2-hour postprandial BG) despite lower baseline glucose levels in this group than in patients with type 2 diabetes. Bodyweight slightly increased in the IGT population. Only 12 acarbose-related adverse events, none of which was serious, were reported. The attending physicians assessed treatment efficacy as ‘good’ or ‘very good’ for 92.4%, tolerability as ‘good’ or ‘very good’ for 91.1%, and patient acceptance as ‘good’ or ‘very good’ for 89.8% of all study participants. Conclusion: Acarbose was efficacious, safe and well accepted by Chinese patients with type 2 diabetes and subjects with IGT under day-to-day treatment conditions, both as monotherapy and in combination with other antihyperglycaemic medication.

The diagnosis of malignant thyroid nodules is still a clinical challenge. This study aimed to determine the ultrasonographic characteristics of papillary thyroid carcinoma. The ultrasonographic and pathological data of 2453 thyroid nodules in a cohort of 1895 Chinese patients who underwent thyroidectomy from January 2010 to December 2012 were retrospectively reviewed. Anteroposterior and transversal (AP/TR) diameters ≥1, solid structure, infiltrative margins, hypoechoic appearance, and microcalcifications were more common in malignant nodules than in benign nodules (P 10 mm). However, in small nodules (diameter ≤10 mm), only AP/TR ≥1 and infiltrative margins were independent risk factors of malignancy (P

Angiotensin II type 1 receptor (AT1R) blockers (ARBs) have been shown to reduce the incidence of type 2 diabetes mellitus; however, the underlying molecular mechanism is unknown. Peroxisome proliferator-activated receptor γ (PPARγ) is the central regulator of insulin and glucose metabolism, which improves insulin sensitivity. Whether candesartan cilexetil, as a prodrug of the AT1R blocker candesartan, has PPARγ-activating properties remains to be elucidated. The aim of the present study was to investigate the effects of oral administration of candesartan cilexetil on glucose tolerance and the actions of PPARγ on liver and adipose tissue in the insulin-resistant obese rat induced by high-fat diet. Animals treated with candesartan cilexetil showed an improved glucose tolerance after oral glucose challenge. Whole-body insulin sensitivity was evaluated using the hyperinsulinemic-euglycemic clamp technique. During high-fat feeding in high-fat diet (HF) rats, the glucose infusion rate (GIR) was 52.3% lower than that in normal chow (NC) rats. However, the GIR was significantly enhanced following candesartan cilexetil treatment. Angiotensin II receptor antagonism also resulted in significant increases in PPARγ protein expression in adipose and liver tissue. These results indicate that PPARγ activation by candesartan cilexetil may provide novel therapeutic options in the treatment of patients with metabolic syndrome.

Aim The aim of this article is to characterize the glucometabolic state of patients with coronary artery disease (CAD) in China. Methods and results This multicentre study recruited 3513 patients hospitalized for CAD, of whom 35.1% were admissions for acute CAD and 64.9% were elective admissions for CAD. At entry, 1153 patients had known type 2 diabetes and 97 had newly diagnosed diabetes [fasting plasma glucose level (FPG) > or =7.0 mmol/L]. Oral glucose tolerance tests (OGTTs) performed in the remaining patients revealed that 26.9% had diabetes and 37.3% had impaired glucose regulation (IGR). The prevalence of abnormal glucose regulation (AGR) was similar in the acute and elective admissions groups. Overall, the proportion of patients with diagnosed diabetes increased from 32.8% at baseline to 52.9% post-OGTT analysis. In total, 87.4% of patients with IGR and 80.5% of patients with diabetes would have remained undiagnosed if OGTTs had not been performed. Conclusion AGR is common in patients with CAD. The prevalence of AGR is underestimated by FPG testing alone. OGTTs should be routinely used to assess the glucometabolic state of patients with CAD. Individuals identified with IGR or type 2 diabetes should receive treatment to reduce the progression of AGR and associated complications.

Aim To describe the clinical, biochemical and immunological characteristics of young-onset diabetes in Asia. Methods Clinical, biochemical and immunological variables were assessed in 919 newly diagnosed (duration less than 12 months) young onset Asian diabetic patients aged between 12 and 40 years. The subjects constituted 57% Chinese, 29% Indians and 14% Malays, recruited from diabetes centres in China, Hong Kong, India, Malaysia and Singapore. Results The mean age (± sd) was 31.6 ± 7.2 years, with the majority (66%) in the 31–40 years age group. Mean body mass index (BMI) (± sd) was 25.3 ± 5.0 kg/m2 with 47% exceeding the suggested Asian cut-off point for obesity (BMI ≥ 25). Ethnic difference in clinical characteristics included BMI, blood pressure, mode of treatment and degree of insulin resistance. Most patients had a clinical presentation of Type 2 diabetes. About 10% had a classical combination of ketotic presentation, presence of autoimmune-markers and documented insulin deficiency indicative of Type 1 diabetes. Forty-eight percent were receiving oral hypoglycaemic agents (OHAs) while 31% were on diet only, 18% were receiving insulin and 2% were on a combination of insulin and OHA. Conclusion Young onset diabetes patients in Asia represent a heterogenous group in terms of their clinical and biochemical characteristics and classical Type 1 diabetes is relatively uncommon. The 5-year follow up study will determine the progress of these patients and help to clarify the natural history.

The aim of this study was to describe the glycaemic and metabolic control and diabetes-related complications in type 1 and type 2 Asian patients.Data of diabetes patients from 230 diabetes centres in 12 Asian regions were collected on a retrospective-prospective basis through review of medical records, interview and laboratory assessments. Analysis of glycated haemoglobin (HbA1c) was carried out in central laboratories appointed by Bio-Rad. The data collection case record forms were scanned electronically.22177 patients with valid data made up the analysis population. Among patents with type 1 and type 2 diabetes, there was a higher proportion of women than men (53% vs. 47% for type 1 patients and 56% vs. 44% for type 2 diabetes). Hypertension (61%) and overweight (40% with BMIor = 25 kg/m2 were common in type 2 patients. Dyslipidaemia was also present in at least half of both types of patients. Control of glycaemia (mean HbA,1c and fasting blood glucose [FBG]) was poor in type 1 (9.9 +/- 2.5%; 10.2 +/- 5.2 mmol/l) and type 2 patients (8.5 +/- 2.0%; 8.9 +/- 3.4 mmol/l). Glycaemia in the majority of both types of patients fell short of those stipulated by various guidelines. In type 2 patients, glycaemia deteriorated (HbA1c7.5%, FBGor = 7.0 mmol/l) with duration of diabetes7 years. Both types of diabetes appear to share a similar high prevalence of complications of cataract, retinopathy and neuropathy, although the prevalence of cataract (27%) and neuropathy (35%) was higher in type 2 diabetes. Screening for microalbuminuria was not common.The Inadequate metabolic and hypertension control, especially in type 2 patients, needs to be addressed.

Background— Microvascular renal and retinal diseases are common major complications of type 2 diabetes mellitus. The relation between plasma lipids and microvascular disease is not well established. Methods and Results— The case subjects were 2535 patients with type 2 diabetes mellitus with an average duration of 14 years, 1891 of whom had kidney disease and 1218 with retinopathy. The case subjects were matched for diabetes mellitus duration, age, sex, and low-density lipoprotein cholesterol to 3683 control subjects with type 2 diabetes mellitus who did not have kidney disease or retinopathy. The study was conducted in 24 sites in 13 countries. The primary analysis included kidney disease and retinopathy cases. Matched analysis was performed by use of site-specific conditional logistic regression in multivariable models that adjusted for hemoglobin A 1c , hypertension, and statin treatment. Mean low-density lipoprotein cholesterol concentration was 2.3 mmol/L. The microvascular disease odds ratio increased by a factor of 1.16 (95% confidence interval, 1.11–1.22) for every 0.5 mmol/L (≈1 quintile) increase in triglycerides or decreased by a factor of 0.92 (0.88–0.96) for every 0.2 mmol/L (≈1 quintile) increase in high-density lipoprotein cholesterol. For kidney disease, the odds ratio increased by 1.23 (1.16–1.31) with triglycerides and decreased by 0.86 (0.82–0.91) with high-density lipoprotein cholesterol. Retinopathy was associated with triglycerides and high-density lipoprotein cholesterol in matched analysis but not significantly after additional adjustment. Conclusions— Diabetic kidney disease is associated worldwide with higher levels of plasma triglycerides and lower levels of high-density lipoprotein cholesterol among patients with good control of low-density lipoprotein cholesterol. Retinopathy was less robustly associated with these lipids. These results strengthen the rationale for studying dyslipidemia treatment to prevent diabetic microvascular disease.

Background The three most commonly used basal insulins in patients with type 2 diabetes are neutral protamine Hagedorn (NPH) insulin and the long-acting insulin analogues glargine and detemir. Although randomised controlled trials have shown equivalent efficacy of these three insulins, inconsistencies in safety exist. We aimed to assess the safety and efficacy of these three basal insulins in real-world clinical setting in the ORBIT (Observational Registry for Basal Insulin Treatment) study. Methods In this multicentre, 6 month, prospective, registry study, patients were recruited between Nov 25, 2011, and Sept 1, 2014, who were aged 18–80 years, with type 2 diabetes that was inadequately controlled (HbA 1C ≥7%, 53 mmol/mol) with oral antidiabetic drugs and who were willing to start treatment with basal insulin were enrolled from 209 hospitals in eight regions of China. Patients who were prescribed any type of insulin in the past 2 years, with clinically significant acute major organ or systemic disease or other condition judged by the investigator that would create difficulty for the 6 month follow-up, or current or planned pregnancy or lactating women were excluded. Type and dose of basal insulin were at the physician's discretion and at the patients' willingness. Assessments were done at baseline (0 month—visit 1), mid-term (3 months—visit 2), and at the end of the study (6 months—visit 3) by investigators during routine practice. During analysis, patients were separated into NPH, glargine, and detemir insulin groups according to their initial prescription of basal insulin. Outcomes included the change in concentration of HbA 1c , hypoglycaemia rate, and bodyweight change in the three groups from baseline to 6 months. Propensity scores with regression adjustment were used to balance the baseline differences among the three groups. Intention-to-treat analysis was used to assess the outcomes. Findings Our findings show that treatment with long-acting insulin analogues is associated with better glycaemic control and less hypoglycaemia and weight gain than treatment with NPH insulin in patients with type 2 diabetes. Interpretation 16 341 patients were analysed in the intention-to-treat group and 9002 were analysed in the per-protocol group. In the intention-to-treat population, there were 11 290 (69%) patients treated with glargine, 2135 (13%) patients treated with detemir, and 18% (2916) patients treated with NPH insulin. After controlling for the baseline and process variables in the propensity score regression, the intention-to-treat analysis showed that the reductions in HbA 1c in the glargine (2%, SD 2·1, p=0·0014) and detemir (2%, 2·1, p=0·0065) groups were higher than that in the NPH group (2%, 2·2). The detemir group had lower weight gain (−0·1 kg, SD 2·9) than the glargine group (0·1 kg, 3·0; p=0·032) and the NPH group (0·3 kg, 3·1; p Funder Sanofi (Shanghai, China).

An 18-year-old male patient had presented with diffuse hyperpigmentation after birth and with adrenal insufficiency syndrome since childhood. After puberty, no secondary sexual signs developed. Laboratory examination showed an extremely high concentration of serum triglycerides (9.14 mmol/L) and plasma adrenocorticotropic hormone (>275 pmol/L), however, a low concentration of plasma free cortisone (

SummaryWhat is known and objective There are acknowledged benefits to continuing metformin when initiating insulin, but there appears to be growing concern over the role of sulphonylureas and thiazolidinediones when used in combination with insulin. This analysis investigates the effects of continuing or discontinuing oral antidiabetic drugs (OADs) following the initiation of once-daily insulin detemir. Methods SOLVE is a 24-week, multinational observational study of insulin detemir initiation in patients with type 2 diabetes mellitus treated with one or more OADs. Results In the total cohort (n = 17 374), there were significant improvements in HbA1c (−1·3%, 95% CI −1·34; −1·27%) and weight (−0·6 kg, 95% CI −0·65; −0·47 kg), with an increase in the incidence rate of minor hypoglycaemia (+0·256 events ppy, P

The aim was to determine the burden of diabetes mellitus (DM) in an urban area of China to aid us in planning preventive measures for those at risk of DM. A survey was conducted among the 29,859 subjects aged between 30 and 64 belonging to 32 units of the Shougang Corporation (a heavy industry enterprise) within the Beijing area. WHO study protocols and diagnostic criteria were used to determine the prevalence of DM and impaired glucose tolerance (IGT). The results showed that the age-adjusted prevalence of DM and impaired glucose tolerance (IGT) was 3.63% and 4.19%, respectively, both increasing with age. Peak prevalence for both occurred in the 60-64 age group. Prevalence showed no difference between the sexes in DM but was higher for females in IGT. Obesity, being overweight, a family history of diabetes mellitus and in women, a history of delivering babies with macrosomia, all correlated closely with the prevalence of DM and IGT. High protein intake was also associated with DM, Smoking had no effect on either DM or IGT. Intellectual workers had a higher incidence of IGT than manual workers. Seventy per cent DM was undiagnosed prior to the survey. This survey, done according to the recommendation of WHO, and including appropriate adjustments, reflects the growing prevalence of DM and IGT in this population. It can be compared with other studies for epidemiological analysis.

Steroid 5α-reductase type 2 deficiency (5α-RD2) is a rare autosomal recessive inherited disorder caused by mutations in the SRD5A2 gene. Its clinical features and pathogenesis in Chinese patients are poorly understood. This study aimed to characterize the clinical features and genetically analyze the SRD5A2 gene in three Chinese 5α-RD2 patients. The patients were characterized by ambiguous genitalia and spontaneous virilization without breast development at puberty. Elevated post-human chorionic gonadotropin stimulation T/DHT ratios were useful indicators of 5α-RD2 (with ratios of 20.4, 20.1, and 26.6 in the three patients, respectively). Two compound heterozygous mutations in the SRD5A2 gene were identified: p.G203S/p.R246Q in patients 1 and 2 and p.G203S/c.655delT in patient 3. The father and the mother of patients 1 and\xa02 were carriers of p.R246Q and p.G203S, respectively. p.G203S appears to be common in Chinese 5α-RD2 patients. Early genetic analysis should be performed in suspected patients to improve prognosis.

The aims of this study were to investigate the prevalence of ED in Chinese men with type 2 diabetes mellitus, and evaluate the efficacy and safety of sildenafil citrate in these patients. Patients from 42 outpatient diabetes clinics with type 2 diabetes mellitus and ED as defined by the International Index of Erectile Function (IIEF)-5 were studied. Participants with ED received three doses (100 mg each) of sildenafil citrate for use over 3 months. Efficacy of sildenafil citrate was assessed using the IIEF-5 and the Global Efficacy Questionnaire (GEQ). Adverse events were recorded by patients in a daily diary. A total of 5477 participants were evaluated, and 75.2% had ED. Age, duration of diabetes and glycosylated hemoglobin (HbA1c) >6.5% were independently and significantly associated with the presence and degree of ED. Patients who received pharmacotherapy (N=389) reported significant improvements. The rate of erections as determined by the GEQ was also significantly improved following treatment. ED is a common complication in Chinese men with type 2 diabetes mellitus, and certain risk factors are associated with the presence of ED and severity. Sildenafil citrate is a safe and effective treatment for these patients.

Udgivelsesdato: 2010-Apr-22 BACKGROUND: The ability of short-acting insulin secretagogues to reduce the risk of diabetes or cardiovascular events in people with impaired glucose tolerance is unknown. METHODS: In a double-blind, randomized clinical trial, we assigned 9306 participants with impaired glucose tolerance and either cardiovascular disease or cardiovascular risk factors to receive nateglinide (up to 60 mg three times daily) or placebo, in a 2-by-2 factorial design with valsartan or placebo, in addition to participation in a lifestyle modification program. We followed the participants for a median of 5.0 years for incident diabetes (and a median of 6.5 years for vital status). We evaluated the effect of nateglinide on the occurrence of three coprimary outcomes: the development of diabetes; a core cardiovascular outcome that was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure; and an extended cardiovascular outcome that was a composite of the individual components of the core composite cardiovascular outcome, hospitalization for unstable angina, or arterial revascularization. RESULTS: After adjustment for multiple testing, nateglinide, as compared with placebo, did not significantly reduce the cumulative incidence of diabetes (36% and 34%, respectively; hazard ratio, 1.07; 95% confidence interval [CI], 1.00 to 1.15; P=0.05), the core composite cardiovascular outcome (7.9% and 8.3%, respectively; hazard ratio, 0.94, 95% CI, 0.82 to 1.09; P=0.43), or the extended composite cardiovascular outcome (14.2% and 15.2%, respectively; hazard ratio, 0.93, 95% CI, 0.83 to 1.03; P=0.16). Nateglinide did, however, increase the risk of hypoglycemia. CONCLUSIONS: Among persons with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors, assignment to nateglinide for 5 years did not reduce the incidence of diabetes or the coprimary composite cardiovascular outcomes. (ClinicalTrials.gov number, NCT00097786.)

Udgivelsesdato: 2010-Apr-22 BACKGROUND: It is not known whether drugs that block the renin-angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance. METHODS: In this double-blind, randomized clinical trial with a 2-by-2 factorial design, we assigned 9306 patients with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors to receive valsartan (up to 160 mg daily) or placebo (and nateglinide or placebo) in addition to lifestyle modification. We then followed the patients for a median of 5.0 years for the development of diabetes (6.5 years for vital status). We studied the effects of valsartan on the occurrence of three coprimary outcomes: the development of diabetes; an extended composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, arterial revascularization, or hospitalization for unstable angina; and a core composite outcome that excluded unstable angina and revascularization. RESULTS: The cumulative incidence of diabetes was 33.1% in the valsartan group, as compared with 36.8% in the placebo group (hazard ratio in the valsartan group, 0.86; 95% confidence interval [CI], 0.80 to 0.92; P

This study investigated the role of homocysteine thiolactone (HcyT) in the development of macrovascular complications in Chinese patients with type 2 diabetes. HcyT has been proposed as a possible molecular basis for homocysteine (Hcy)-induced vascular damage.One hundred and sixty subjects were recruited into this study: 40 healthy controls and 120 patients with type 2 diabetes. Plasma Hcy levels were measured by polarization immunoassay and HcyT concentrations were monitored using high-performance liquid chromatography on a reversephase C18 column with ultraviolet detection. Plasma folic acid and vitamin B(12) levels were measured using radioimmunoassay methods.Plasma Hcy and HcyT concentrations in patients with type 2 diabetes were significantly higher than in healthy controls (Hcy [25th and 75th quartiles]: 9.28 [7.51-11.82] vs. 5.64 [5.17-8.00] micromol/L, P=0.01; HcyT: 3.38 [2.94-4.73] vs. 2.91 [2.77-3.08] nmol/L, P0.05). Plasma Hcy and HcyT levels in patients with macrovasculopathy (MAVP) were significantly higher compared with patients without MAVP (Hcy: 10.36 [7.67-12.45] vs. 7.85 [6.76-10.52] micromol/L, P0.05; HcyT: 4.27 [3.02-5.11] vs. 3.12 [2.63-3.77] nmol/L, P0.05). Plasma HcyT concentrations were positively correlated with urinary excretion of albumin/creatinine (Alb/Cr; r=0.285, P=0.007), duration of diabetes (r=0.249, P=0.019), age (r=0.233, P=0.028), and fibrinogen levels (r=0.289, P=0.034). Plasma HcyT concentrations were negatively correlated with high-density lipoprotein levels (r=-0.223, P=0.037). Binary logistic regression showed that HcyT, Hcy, smoking, serum triglyceride, and urine Alb/Cr were significantly associated with the risk of diabetic MAVP (P0.05).Hcy and HcyT levels were associated with the development and progression of diabetic MAVP. HcyT may provide a plausible chemical mechanism for explaining Hcy toxicity in the human vascular endothelium.

Microalbuminuria (MA) is a risk marker for diabetic nephropathy and cardiovascular (CV) disease (CVD) in patients with diabetes. This study aimed to describe the prevalence of albuminuria, CV risk factors, and treatments for renal and CV protection in an Asian population with type 2 diabetes.This cross-sectional study conducted in eight Asian countries enrolled normotensive/hypertensive adults with type 2 diabetes without known proteinuria and/or non-diabetic kidney disease. Exclusion criteria were type 1 diabetes, menstruation, pregnancy, and acute fever. A single random urinary albumin/creatinine test was carried out in all patients.Of 8,561 patients, 14% had diabetic retinopathy, and 17% and 21% had history of CV disease and smoking, respectively. Normoalbuminuria was seen in 44%, MA in 44%, and macroalbuminuria in 12%. Target glycosylated hemoglobin (HbA1c) (7%) was reached in only 37% of 3,834 patients with available values. Diabetes was managed by diet alone in 6%, while others received oral hypoglycemic drugs and/or insulin. In total, 75% did not reach target blood pressure (BP) ofor=130/80 mm Hg. Antihypertensive drugs were prescribed to 52%, with the number of drugs increasing as the level of systolic BP increased. Drugs blocking the renin-angiotensin system were most commonly prescribed, followed by calcium channel blockers. Lipid-lowering drugs and anticoagulant/antiplatelet agents were used in about 30% and 25% of patients, respectively.Asian patients with type 2 diabetes had a high prevalence of MA and reduced kidney function. Furthermore, BP and HbA1c control was only achieved in a minority of patients. Aggressive risk management by administration of reno- and cardioprotective treatments is urgently needed.

The severity of the type 2 diabetes epidemic is widely acknowledged. Demographic, social, and cultural changes around the world are driving a dramatic increase in the prevalence of type 2 diabetes. Consequently, there is increasing interest in defining the target population and developing strategies for preventing or delaying the disease. Impaired glucose tolerance (IGT), an asymptomatic condition early in the disease continuum of dysglycemia, is the best target for intervention, as it is a strong predictor for the development of both type 2 diabetes and cardiovascular disease (CVD). Identifying individuals likely to have IGT using risk-prediction tools is simple and cost-effective; diagnosis can be confirmed with an oral glucose tolerance test. Numerous trials have examined the benefits of intervention in IGT populations. Lifestyle modification and some pharmacologic therapies, such as acarbose, have been shown to significantly reduce disease progression. Acarbose therapy has also been associated with significant reductions in cardiovascular events and new cases of hypertension. Trials assessing the potential preventive effects of various therapies are ongoing, but current evidence confirms that early intervention in individuals with IGT can reduce the risks of type 2 diabetes and CVD. Identification of high-risk individuals should therefore be standard in general practice and, if IGT is diagnosed, therapeutic intervention should be initiated promptly.

To evaluate the superiority of insulin glargine as basal insulin replacement by continuous glucose monitoring system (CGMS). Twenty-four patients with type 2 diabetes mellitus (T2DM) whose blood glucose was not well controlled with sulphanylureas were enrolled. At first, they were treated with extended-release glipizide (glucotrol XL) 5mg/d before breakfast for 2 weeks, then randomized to combination treatment with glargine (16 patients) or NPH (8 patients) and treated for 12 weeks. CGMS were carried in the second week after treatment with glucotrol XL, and in the 12th week after combination treatment. The data of CGMS showed: (1) When FPG were well controlled in both groups (glargine group versus NPH group: 6.0+/-1.0 mmol/L versus 5.8+/-1.3 mmol/L), the blood glucose level at 3:00 a.m. (5.1+/-0.9 mmol/L versus 4.2+/-0.8 mmol/L) were higher (P