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Diabetic peripheral neuropathy (DPN) is a highly prevalent chronic complication in type 2 diabetes (T2D) for which no effective treatment is available. In this multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial in China, patients with T2D with DPN received acetyllevocarnitine hydrochloride (ALC; 1,500 mg/day; n = 231) or placebo (n = 227) for 24 weeks, during which antidiabetic therapy was maintained. A significantly greater reduction in modified Toronto clinical neuropathy score (mTCNS) as the primary end point occurred in the ALC group (−6.9 ± 5.3 points) compared with the placebo group (−4.7 ± 5.2 points; P < 0.001). Effect sizes (ALC 1.31 and placebo 0.85) represented a 0.65-fold improvement in ALC treatment efficacy. The mTCNS values for pain did not differ significantly between the two groups (P = 0.066), whereas the remaining 10 components of mTCNS showed significant improvement in the ALC group compared with the placebo group (P < 0.05 for all). Overall results of electrophysiological measurements were inconclusive, with significant improvement in individual measurements limited primarily to the ulnar and median nerves. Incidence of treatment-emergent adverse events was 51.2% in the ALC group, among which urinary tract infection (5.9%) and hyperlipidemia (7.9%) were most frequent. Article Highlights: The prevalence of diabetic peripheral neuropathy (DPN) in adults with diabetes is ∼50%, with clinical manifestations of burning, tingling, pain, and progressive numbness. Carnitine insufficiency is associated with increased risk of type 2 diabetes complications, and carnitine therapy reduces fasting plasma glucose and hemoglobin A1c concentrations. Adult patients with DPN were treated with acetyllevocarnitine hydrochloride (ALC) orally while receiving concomitant antidiabetic therapy, which resulted in improved modified Toronto clinical neuropathy scores. Dietary ALC supplementation provides at least some incremental improvement in DPN-related symptoms. [ABSTRACT FROM AUTHOR]

The article reports on incidence of Type 1 Diabetes may be underestimated in the Chinese population. Topics include proportional hazards assumption using plots of log amputation-free survival probability; and statistically significant interaction between type of diabetes and history of foot ulcer in the fully adjusted multivariable model.

Objective: To evaluate the risk factors of cardiovascular autonomic neuropathy(CAN) in Chinese diabetic patients, estimate the optimal CAN diagnostic method to different diabetics, assess CAN prevalence in our dataset. Methods: 2, 048 subjects randomly sampled from 13 hospitals were available for data analysis, including 73 type 1 diabetes mellitus (T1DM) and 1, 975 type 2 diabetes mellitus (T2DM). The general data of patients were collected and sympathetic and parasympathetic function tests were executed to CAN preliminary diagnosis. The final CAN diagnosis was based on Ewing's test in which heart rate variation (HRV values were evaluated through deep-breathing (DB), lying-to-standing (LS), Valsalva (V) tests and systolic blood pressure (SBP) variation values was evaluated through LS. Results: 1) In T1DM group, 61.64% patients were diagnosed with CAN; baseline data and clinical data of CAN group had no difference with those of none-CAN group (P>0.05);while in T2DM group, 62.58% patients were diagnosed with CAN; there were significant differences between CAN and none-CAN group in age, course of the disease, use of metformin, course of metformin treatment, retinopathy and hypertension history (P<0.05). 2) Among various symptoms in CAN group, most frequent symptoms were weakness (28.65%), dizziness (23.42%), frequent urination (19.59%), upper body sweating (18.35%) and enuresisnocturna (15.93%). 3) Course of disease and age were independent risk factors for CAN in T1DM and T2DM, respectively. 4) For T1DM, the optimal CAN diagnostic method was Vtest+LStes (sensitivity=97.62% , AUC=0.887); while for T2DM, DBtest had the highest sensitivity (83.62%) and Vtest+DBtest had the maximal AUC (0.856). Conclusion: The prevalence of diabetes with CAN was up to 63%.The course of disease and age are independent risk factors of CAN in TIDM and T2DM, respectively. Furthermore, Vtest+LStest and Vtest+DBtest were the optimal CAN diagnostic method for T1DM and T2DM, respectively. Disclosure: Q. Pan: None. L. Guo: None. X. Wang: None. L. Zhang: None. T. Xian: None. F. Man: None. L. Liu: None. [ABSTRACT FROM AUTHOR]

Background: Needle free insulin injector is designed for diabetics with needle anxiety or fear of injection pain resulting in reluctance to initiate insulin therapy when it is actually indicated. This device has faster absorption of insulin and has better glycemic control compared with conventional insulin pen. But the efficacy of glycemic control was only evaluated by postprandial blood glucose or the area under blood glucose curve. Objective: To investigate the efficacy of needle free insulin injector by HbA1c level compared with conventional insulin pen in insulin treated type 2 diabetic patients in multicenter, prospective, randomized, open-label trial. Methods: A total of 427 patients with HbA1c levels of ≥7.5% to ≤11% while receiving basal or premixed insulin were randomized 1:1 to needle free insulin injector group (NFII) or conventional insulin pen group (CIP). The primary efficacy endpoint was change of HbA1c leve after 16 weeks treatment. The change of 7-point blood glucose profile and the percentage of patients with HbA1c level <7% were also observed. Results: Of the 412 patients (mean age 57.92±10.03ys; BMI 28.33±2.96kg/m2; HbA1c 8.25±1.00%) who completed the study, 206 patients were insulin treated via NFII and 206 via CIP. There were no significant differences in baseline characteristics between the two groups (P> 0.05). The HbA1c reduction 0.55% (95% CI: -0.71, -0.39) at week 16 in NFII group was non-inferior and statistically superior compared with that of 0.26% (95% CI: -0.42, -0.11) in CIP group. There were no differences between two groups in the percentages of patients achieving the HbA1c target (27.32% vs. 24.26%; P> 0.05) or in the change of 7-point blood glucose profile at week 16. Conclusions: The device non-inferior and statistically superior efficacy in glycemic control compared to conventional insulin pen in insulin-treated type 2 diabetic Patients in China. Disclosure: L. Gao: None. L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck KGaA, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Roche Pharma, Sanofi. L. Guo: None. Y. Wang: None. L. Chen: Research Support; Self; Becton, Dickinson and Company. G. Wang: None. X. Ran: None. X. Xu: None. Z. Sun: None. Z. Ma: None. Z. Shan: None. [ABSTRACT FROM AUTHOR]

Background: Needle-free insulin delivery has been shown to accelerate the absorption and the action of insulin, and to be well tolerated. Objective: To determine the safety profile of a needle-free injector with that of conventional insulin pen injections in patients with T2DM. Methods: A total of 427 patients with T2DM were enrolled in a multicenter, prospective, randomized, open-label clinical trial, and were randomized 1:1 to receive basal or premixed insulin via a needle-free injector or via conventional insulin pen injections. Adverse events occurring during the study were recorded in the 2 groups, and the incidences of hypoglycemia and injection site reactions were compared. Result: The adverse events rates in the needle-free injector and insulin pen groups were 5.31% and 3.35%, respectively, but no statistically significant difference between the 2 groups (P = 0.3468). Rates of hypoglycemia (25.60% vs. 18.18%, respectively; P = 0.0671), and local injection-site reactions (bleeding/ecchymosis and redness) were also similar in the 2 groups. However, the incidence of skin scratches was decreased significantly in the needle-free injector group (15.53% vs. 23.92%; P = 0.0319). There was no new indurations observed in needle-free injector group compared 4.00% in the conventional insulin pen group (P = 0.006). Patients in the needle-free injector group also showed lower overall VAS pain scores than those in the conventional insulin pen group (mean scores, 1.11 ± 1.21 vs. 1.98 ± 1.99; P < 0.0001). Conclusion: Administration of insulin by a needle-free injector could provide a better safety profile than insulin pen injections, by reducing skin scratches, indurations, and pain. Disclosure: L. Chen: Research Support; Self; Becton, Dickinson and Company. L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck KGaA, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Roche Pharma, Sanofi. Y. Wang: None. Z. Ma: None. X. Ran: None. Z. Sun: None. X. Xu: None. G. Wang: None. L. Guo: None. Z. Shan: None. [ABSTRACT FROM AUTHOR]