Search

Aims: To provide real‐world data on the addition of basal insulin (BI) in people with type 2 diabetes mellitus (PWD2) suboptimally controlled with glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) therapy. However, real‐world data on the addition of BI to GLP‐1RA therapy are limited. Materials and Methods: We used a US electronic medical record data source (IBM® Explorys®) that includes approximately 4 million PWD2 to assess the real‐world impact of adding the second‐generation BI analogue insulin glargine 300 U/mL (Gla‐300) to GLP‐1RA therapy. Insulin‐naïve PWD2 receiving GLP‐1RAs who also received Gla‐300 between March 1, 2015 and September 30, 2019 were identified; participants were required to have data for ≥12 months before, and ≥6 months after, addition of Gla‐300. Results: The mean (standard deviation [SD]) age of participants (N = 271) was 57.9 (10.8) years. Baseline glycated haemoglobin (HbA1c) was 9.16% and was significantly reduced (−0.97 [SD 1.60]%; P < 0.0001) after addition of Gla‐300; a significant increase in the proportion of PWD2 achieving HbA1c control was observed after addition of Gla‐300 (HbA1c <7.0%: 4.80% vs. 22.14%, P < 0.0001; HbA1c <8.0%: 19.56% vs. 51.29%, P < 0.0001). The incidence of overall (8.49% vs. 9.59%; P = 0.513) and inpatient/emergency department (ED)‐associated hypoglycaemia (0.37% vs. 0.74%; P = 1.000), as well as overall (0.33 vs. 0.46 per person per year [PPPY]; P = 0.170) and inpatient/ED‐associated hypoglycaemia events (0.01 vs. 0.04 PPPY; P = 0.466) were similar before and after addition of Gla‐300. Conclusions: In US real‐world clinical practice, adding Gla‐300 to GLP‐1RA significantly improved glycaemic control without significantly increasing hypoglycaemia in PWD2. Further research into the effect of adding Gla‐300 to GLP‐1RA therapy is warranted. [ABSTRACT FROM AUTHOR]

Video abstract: View a video abstract for this article. Aims: This multicentre (N = 104), randomized controlled phase 4 study compared the efficacy and safety of insulin glargine 300 units/mL (Gla‐300) with insulin glargine 100 units/mL (Gla‐100) in patients with type 1 diabetes (T1D). Materials and methods: Patients were randomized 1:1 to self‐perform morning Gla‐300 or Gla‐100 injections daily for 16 weeks. The primary endpoint was percentage of time blood glucose remained in the target range (70–180 mg/dL) during Week 15/16, measured by blinded continuous glucose monitoring. Secondary endpoints included incidence and rate of nocturnal symptomatic hypoglycaemia (≤70 mg/dL), glycaemic variability parameters and safety assessments. Exploratory analyses were performed in patients with glycated haemoglobin (HbA1c) <7.5% at Week 16. Results: Overall, 638 patients with T1D were included (Gla‐300, n = 320; Gla‐100, n = 318). In the modified intent‐to‐treat (mITT) population, no differences between Gla‐300 and Gla‐100 were observed in time in range, in glycaemic variability, or in incidence or rates of nocturnal symptomatic hypoglycaemia. In exploratory analyses of patients with HbA1c <7.5% at Week 16, Gla‐300 recipients had greater improvement in time in range over 24 hours, during the day and at night compared with Gla‐100 recipients (P < 0.05), with small increases in overall hypoglycaemia. Conclusions: Time in range and glycaemic variability were similar for Gla‐300 and Gla‐100 recipients at the end of study in the mITT population of relatively well‐controlled patients with T1D. In patients with end‐of‐study HbA1c <7.5%, exploratory analyses suggested that Gla‐300 provided improvements in time in range compared with Gla‐100. [ABSTRACT FROM AUTHOR]

Introduction: Persistence with basal insulin therapy can be suboptimal, despite recent improvements in insulin formulations and delivery systems. Patient support programs may help increase adherence. This study evaluated the impact of the Toujeo® COACH support program, which provides patients with continuing and individualized education and advice on lifestyle changes, by assessing its effect on number of refills and days on therapy.Methods: The study population included 1724 patients with diabetes who filled a first prescription for insulin glargine 300 U/mL (Gla-300) between April and December 2015 and received a welcome call from a Guide, and 1724 matched control patients from the Symphony Health Integrated Dataverse® prescription claims database. Control patients received Gla-300 but did not enroll in the program. These patients were matched based on age, gender, location, prior use of insulin, insulin dose, number of concomitant drugs, and copay tier.Results: The COACH and control groups comprised 52% men and 48% women; 22% were aged 18-47 years, 23% were 48-55 years, 27% 56-61 years, and 28% ≥ 62 years. Most (99%) had used insulin in the year before receiving the welcome call. At 6 months, patients in the COACH group had refilled their prescription 3.2 times on average, compared with 2.4 times for control patients (P < 0.0001); at 9 months, the average number of refills was 4.7 and 3.6, respectively (P < 0.0001). The average number of days on therapy at 6 months was 102.2 days in the COACH group and 81.5 days in the control group (P < 0.0001); at 9 months, the average number of days on therapy was 151.9 and 121.6, respectively (P < 0.0001).Conclusion: Patients in the COACH program were significantly more likely to refill their prescriptions and stay on therapy. Patient support programs such as the COACH program could be an effective way to help improve diabetes care.Funding: Sanofi US, Inc. and McKesson Corporation. [ABSTRACT FROM AUTHOR]

This retrospective observational study using the Optum Clinformatics claims database included data from adults (≥18 y) with T2D who had received prior basal insulin (BI) (NPH, Gla-100, IDet) in the 6-month baseline period, and switched to either the second-generation (2nd-gen) BI, Gla-300 or a first-generation (1st-gen) BI (Gla-100, IDet) (treatment switch=index date) between April 1, 2015 and August 31, 2019. Participants were followed from index date for 12 months or plan disenrollment or death. Cohorts were propensity score matched (PSM) on baseline demographic/clinical characteristics. Outcomes were persistence (days on treatment without discontinuation), adherence (proportion days covered), healthcare resource utilization and costs. After PSM (n=3077/cohort; mean age 68 y, 52% female), cohorts were well balanced except for 1 variable (hospitalization) with standardized difference >0.1, which was adjusted in models as a covariate. During the 12-month follow-up period, higher proportions of participants who received Gla-300 vs. 1st-gen BI were persistent (45.5 vs. 42.1%; adjusted p=.0001) and adherent (42.8 vs. 38.2%; adjusted p=.0006). All-cause healthcare resource utilization was lower for Gla-300 vs. 1st-gen BI (emergency room visits 111.9 vs. 148.8 events per 100 patient-years [PY]; inpatient hospitalizations 45.3 vs. 65.9 events per 100 PY; adjusted p<.0001). Total healthcare costs were numerically lower for Gla-300 vs. 1st-gen BI ($41,255 vs. $45,316 per PY). Switching to Gla-300 was associated with significantly better persistence, adherence, and—despite these associated costs—lower all-cause healthcare resource utilization vs. switching to a 1st-gen BI, in people with T2D previously treated with BI therapy. This is the first study to assess these outcomes in tandem. Disclosure: E. Wright: Advisory Panel; Self; Abbott Diabetes, Bayer Healthcare Pharmaceuticals Inc., Boehringer Ingelheim International GmbH, Sanofi, Consultant; Self; Abbott Diabetes, Boehringer Ingelheim Pharmaceuticals, Inc., Other Relationship; Self; American Diabetes Association, Speaker's Bureau; Self; Bayer Healthcare Pharmaceuticals Inc., Sanofi. J. Gill: Employee; Self; Sanofi US, Other Relationship; Self; American Diabetes Association, Stock/Shareholder; Self; Sanofi US. S. Huse: Consultant; Self; Sanofi US. X. Li: Employee; Self; Sanofi US. T. Reid: Other Relationship; Self; Sanofi US. F. L. Zhou: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. Funding: Sanofi US [ABSTRACT FROM AUTHOR]

Background: This analysis assessed the cost‐effectiveness of insulin glargine 300 units/mL (Gla‐300) versus insulin glargine 100 units/mL (Gla‐100) in insulin‐naïve adults with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs (OADs). Methods: Costs and outcomes for Gla‐300 versus Gla‐100 from a US healthcare payer perspective were assessed using the BRAVO diabetes model. Baseline clinical data were derived from EDITION‐3, a 12‐month randomized controlled trial comparing Gla‐300 with Gla‐100 in insulin‐naïve adults with inadequately controlled T2D on OADs. Treatment costs were calculated based on doses observed in EDITION‐3 and 2020 US net prices, while costs for complications were based on published literature. Lifetime costs ($US) and quality‐adjusted life‐years (QALYs) were predicted and used to calculate incremental cost‐effectiveness ratio (ICER) estimates; extensive scenario and sensitivity analyses were conducted. Results: Lifetime medical costs were estimated to be $353,441 and $352,858 for individuals receiving Gla‐300 and Gla‐100 respectively; insulin costs were $52,613 and $50,818. Gla‐300 was associated with a gain of 8.97 QALYs and 21.12 life‐years, while Gla‐100 was associated with a gain of 8.89 QALYs and 21.07 life‐years. This resulted in an ICER of $7522/QALY gained for Gla‐300 versus Gla‐100. Thus, Gla‐300 was cost‐effective versus Gla‐100 based on a willingness‐to‐pay threshold of $50,000/QALY. Compared with Gla‐100, Gla‐300 provided a net monetary benefit of $3290. Scenario and sensitivity analyses confirmed the robustness of the base case. Conclusion: Gla‐300 may be a cost‐effective treatment option versus Gla‐100 over a lifetime horizon for insulin‐naïve people in the United States with T2D inadequately controlled on OADs. [ABSTRACT FROM AUTHOR]

ACHIEVE Control, a pragmatic randomized real-world clinical trial, prospectively compared the effectiveness and safety of Gla-300 vs. SoC-BIs (glargine 100 U/mL and detemir) in a broad primary care and specialist population of insulin-naive patients with A1C ≥8% despite using ≥2 antihyperglycemia agents for ≥1 year. The pre-specified 6-month outcomes showed superiority of Gla-300 in achieving the composite primary endpoint: 31.3% of patients using Gla-300 (vs. 27.9% of patients using SoC-BIs; p=0.03) attained individualized HEDIS A1C targets (A1C <8% if age ≥65 years or with defined comorbidities; A1C <7% otherwise) without severe (requiring external assistance) and/or symptomatic documented hypoglycemia (≤70 mg/dL). We report 12-month outcomes, which provide valuable insights on longer-term effectiveness and safety. At 12 months, 26.1% of patients using Gla-300 (vs. 23.7% using SoC-BIs) met the composite endpoint (odds ratio [OR] 1.14, 95% CI 0.97-1.35), and more attained HEDIS A1C targets without ADA-defined clinically significant (Level 2) hypoglycemia (<54 mg/dL) with Gla-300 vs. SoC-BIs (33.0% vs. 29.5%; OR 1.19, CI 1.02-1.38]). A1C reductions seen at 6 months were maintained to 12 months and comparable in patients using Gla-300 vs. SoC-BIs (mean change from baseline: -1.31% vs.-1.26%; nominal p=0.325). Similar mean changes from baseline in body weight (Gla-300: +1.55kg; SoC-BIs: +1.39kg) and insulin dose (+0.22 U/kg; both groups) were observed at 12 months. Drug-related treatment-emergent adverse events were similar across groups. In summary, the 12-month analysis of the ACHIEVE Control study translated the findings of improved clinical outcomes for Gla-300 vs. SoC-BIs previously seen in randomized controlled trials to a broader real-world population managed in a usual care setting. Disclosure: L. Meneghini: Advisory Panel; Self; AstraZeneca, Novo Nordisk Inc., Sanofi-Aventis. Consultant; Self; Sanofi-Aventis. Other Relationship; Self; American Diabetes Association. J. Gill: Employee; Self; Sanofi. A. Dauchy: None. A. Bacevicius: Employee; Self; Sanofi. J. Strong: Advisory Panel; Self; Novo Nordisk Inc., Sanofi. Speaker's Bureau; Self; Abbott, American Diabetes Association, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi. T.S. Bailey: Advisory Panel; Self; Abbott. Consultant; Self; Capillary Biomedical, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Sanofi. Research Support; Self; Abbott, Ascensia Diabetes Care, Becton, Dickinson and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Calibra Medical, Capillary Biomedical, Inc., Companion Medical, Dance Biopharm Holdings Inc., Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, GlySens Incorporated, Kowa Pharmaceutical Europe Co. Ltd., Lexicon Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., POPS! Diabetes Care, POPS! Diabetes Care, Sanofi, Senseonics, vTv Therapeutics, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. Speaker's Bureau; Self; Abbott, MannKind Corporation, Medtronic, Novo Nordisk Inc., Sanofi US, Senseonics. Funding: Sanofi [ABSTRACT FROM AUTHOR]

Aim: To report the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) versus standard-of-care basal insulin analogues (SOC-BI) at 12 months in the ACHIEVE Control trial, which is a prospective pragmatic randomized real-life study in insulin-naïve adults with type 2 diabetes (T2D). Methods: A total of 3304 insulin-naïve adults with T2D and glycated haemoglobin (HbA1c) concentration of 64 to 97 mmol/mol (8.0% to 11.0%) after ≥1 year of treatment with two or more antihyperglycaemic agents were randomized to Gla-300 or SOC-BI. Key secondary endpoints included HbA1c target attainment without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia at 12 months. Results: At 12 months, 26.1% (Gla-300) and 23.7% (SOC-BI) of adults achieved HbA1c targets without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia (odds ratio [OR] 1.14, 95% confidence interval [CI] 0.97-1.35); 33.0% and 29.5%, respectively, achieved HbA1c targets without documented symptomatic (<3.0 mmol/L [<54 mg/dL]) or severe hypoglycaemia (OR 1.19, 95% CI 1.02-1.38). The OR for HbA1c target achievement was 1.15 (95% CI 0.99-1.34), and favoured Gla-300 versus SOC-BI for absence of documented symptomatic or severe hypoglycaemia at 12 months for both ≤3.9 mmol/L (≤70 mg/dL; OR 1.21, 95% CI 1.05-1.40) and < 3.0 mmol/L (<54 mg/dL; OR 1.26, 95% CI 1.07-1.48). Conclusion: Gla-300 tended to be associated with lower hypoglycaemia risk than SOC-BI in real-world clinical practice during the 12-month follow-up. [ABSTRACT FROM AUTHOR]

Aims: A cost‐effectiveness analysis was conducted to compare insulin glargine 300 U/mL (Gla‐300) versus insulin degludec 100 U/mL (IDeg‐100) in insulin‐naïve adults with type 2 diabetes (T2D) sub‐optimally controlled with oral anti‐diabetic drugs (OADs). Methods: The BRAVO diabetes model was used to assess costs and outcomes for once‐daily Gla‐300 versus once‐daily IDeg‐100 from a US healthcare sector perspective. Baseline clinical data were based on BRIGHT, a 24‐week, non‐inferiority, randomised control trial comparing Gla‐300 and IDeg‐100 in adults with T2D sub‐optimally controlled with OADs (with or without glucagon‐like peptide‐1 receptor agonists). Treatment costs were based on doses observed in BRIGHT as well as net prices. Costs associated with complications were based on published literature. Lifetime costs (US$) and quality‐adjusted life‐years (QALYs) were predicted and used to calculate incremental cost‐effectiveness ratio estimates; extensive scenario and sensitivity analyses were conducted. Results: Overall lifetime medical costs were estimated to be $327,904 and $330,154 for people receiving Gla‐300 and IDeg‐100, respectively; insulin costs were $43,477 and $44,367, respectively. People receiving Gla‐300 gained 8.024 QALYs and 18.55 life‐years, while people receiving IDeg‐100 gained 7.997 QALYs and 18.52 life‐years. Because Gla‐300 was associated with a cost‐saving of $2250 and 0.027 additional QALYs, it was considered to be dominant compared with IDeg‐100. Results of the scenario and sensitivity analyses confirmed the robustness of the base case results. Conclusion: Gla‐300 was the dominant treatment option compared with IDeg‐100 based on the willingness‐to‐pay threshold of $50,000/QALY. Results remained robust against a wide range of alternative assumptions on key parameters. [ABSTRACT FROM AUTHOR]

People with type 2 diabetes receiving a second-generation basal insulin (BI) analog may be switched to a first-generation formulation for financial reasons or changes in health insurance. However, because second-generation BI analogs have more even pharmacokinetic profiles, longer durations of action (>24 vs. ≤24 hours), and more stable action profiles than first-generation BI analogs, such a change may result in suboptimal treatment persistence and/or adherence. This study compared treatment persistence, treatment adherence, rates of hypoglycemia, and health care resource utilization outcomes in people with type 2 diabetes who either continued treatment with the second-generation BI Gla-300 or switched to a first-generation BI. The study showed that continuing with Gla-300 was associated with a lower risk of discontinuing therapy, fewer emergency department visits, and lower hypoglycemia event rates than switching to a first-generation BI. [ABSTRACT FROM AUTHOR]

Abstract Objectives: This study aimed to examine healthcare provider (HCP) recommendations and patient preferences for the insulin pen versus vial-and-syringe in patients with type 2 diabetes mellitus (T2DM) and to assess clinical end points and safety outcomes. Subjects and Methods: Using a randomized, open-label, crossover design, in total, 405 insulin-naive adults with T2DM from 60 centers received basal insulin glargine in one of two device treatment sequences (2 weeks of pen followed by 2 weeks of vial-and-syringe, or vice versa). The primary end point, patient device preference, was evaluated at Week 4 (end of the crossover period) using the Insulin Injection Preference Questionnaire. Patient preference and HCP recommendation were assessed with one global item and three subscale items (blood glucose control, reluctance to use insulin, and long-term insulin use) using a 5-point scale ranging from 1=not preferred or not recommended to 5=preferred or recommended. Patients were then re-randomized to either pen or vial-and-syringe for further observation (6, 10, and 30 weeks) to evaluate clinical end points (glycosylated hemoglobin [A1C] and fasting blood glucose levels) and safety outcomes (hypoglycemia and adverse events). Results: Patients reported a significant preference for pens over vial-and-syringe, and HCPs strongly recommended pens over vial-and-syringe (both P<0.001). Consistent response patterns were observed by HCPs and patients for the three subscale items. Fasting blood glucose, A1C levels, and the incidence of hypoglycemia were comparable in the two groups. Conclusions: Patients preferred pens over vial-and-syringe, with the pen device also recommended by HCPs, when initiating basal insulin treatment in insulin-naive patients with T2DM. [ABSTRACT FROM AUTHOR]

Aims: To compare the safety and efficacy of insulin glargine 300 U/mL (Gla-300) versus first-generation standard-of-care basal insulin analogues (SOC-BI; insulin glargine 100 U/mL or insulin detemir) at 6 months. Methods: In the 12-month, open-label, multicentre, randomized, pragmatic ACHIEVE Control trial, insulin-naïve adults with type 2 diabetes (T2D) and glycated haemoglobin (HbA1c) 64 to 97 mmol/mol (8.0%-11.0%) after ≥1 year of treatment with ≥2 diabetes medications were randomized to Gla-300 or SOC-BI. The composite primary endpoint, evaluated at 6 months, was the proportion of participants achieving individualized HbA1c targets per Healthcare Effectiveness Data and Information Set (HEDIS) criteria without documented symptomatic (blood glucose ≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia at any time of the day at 6 months. Results: Of 1651 and 1653 participants randomized to Gla-300 and SOC-BI, respectively, 31.3% and 27.9% achieved the composite primary endpoint at 6 months (odds ratio [OR] 1.19, 95% confidence interval [CI] 1.01-1.39; P = 0.03 for superiority); 78.4% and 75.3% had no documented symptomatic or severe hypoglycaemia (OR 1.19, 95% CI 1.01-1.41). Changes from baseline to month 6 in HbA1c, fasting plasma glucose, weight, and BI analogue dose were similar between groups. Conclusions: Among insulin-naïve adults with poorly controlled T2D, Gla-300 was associated with a statistically significantly higher proportion of participants achieving individualized HEDIS HbA1c targets without documented symptomatic or severe hypoglycaemia (vs SOC-BI) in a real-life population managed in a usual-care setting. The ACHIEVE Control study results add value to treatment decisions and options for patients, healthcare providers, payers and decision makers. [ABSTRACT FROM AUTHOR]

Abstract Objective: The study was designed to evaluate real-world data on clinical and economic outcome differences between patients with type 2 diabetes mellitus (T2DM) who use insulin glargine with vial-and-syringe delivery and those who switch to pen administration. Subjects and Methods: This retrospective study analyzed medical and pharmacy claims information from the national managed-care IMPACT database (Ingenix Inc., Salt Lake City, UT). Adults with T2DM treated with insulin glargine were evaluated. Clinical and economic outcomes over 1 year were compared between individuals who had converted from administering glargine via vial-and-syringe to the SoloSTAR (sanofi-aventis U.S., Bridgewater, NJ) pen (Switchers) and patients who continued to use vial-and-syringe administration (Continuers). Patients from each cohort were matched using propensity score matching for a comparison sample. Results: In total, 3,893 eligible patients were identified (665 Switchers and 3,228 Continuers), with a matched cohort with 603 patients in each group. Baseline characteristics were similar between groups. One-year treatment persistence was significantly higher with Switchers versus Continuers (65.3% vs. 49.8%; P<0.0001). Medication possession ratio was also significantly higher among Switchers (0.79 vs. 0.76; P=0.0173). Insulin use and glycemic control were similar between groups. Healthcare utilization and total costs were also similar between groups. Higher prescription costs among Switchers were offset by lower overall and diabetes-related outpatient and inpatient costs. Conclusions: Switching from insulin glargine vial-and-syringe administration to pen delivery resulted in improved treatment adherence and persistence, with comparable clinical and economic outcomes. [ABSTRACT FROM AUTHOR]

In PWD2 inadequately controlled with GLP-1 RA therapy, addition of basal insulin is recommended. We used a US electronic medical record data source (IBM Explorys) of ~4 million PWD2 to assess the real-world impact of adding the basal insulin analog Gla-300 to GLP-1RA therapy in PWD2. Insulin-naïve PWD2 receiving GLP1-RAs who subsequently received Gla-300 between Mar 1, 2015-Sep 30, 2019 were identified; patients were required to have data for ≥12 months prior, and ≥6-month after, addition of Gla-300. Mean age of participants (N=271) was 57.9 (SD: 10.8) years. Baseline HbA1c was 9.16%, and was significantly reduced (0.97 [SD:1.60], p<0.0001) after addition of Gla-300; a significant increase in proportion of PWD2 achieving HbA1c control was observed after addition of Gla-300 (HbA1c <7.0%: 4.80% vs. 22.14%, p<0.0001; HbA1c <8.0%: 19.56% vs. 51.29%, p<0.0001). Incidence of overall (8.49% vs. 9.59%, p=0.513), and inpatient/emergency room-associated hypoglycemia (0.37% vs. 0.74%, p=1.000), as well as overall (0.33 vs. 0.46 PPPY, p=0.170) and inpatient/emergency room-associated hypoglycemia events (0.01 vs. 0.04 PPPY, p=0.466) were similar before and after addition of Gla-300. In US RW clinical practice, adding Gla-300 to GLP-1 RA significantly improved glycemic control without significantly increasing hypoglycemia. Disclosure: T. S. Bailey: Consultant; Self; Abbott Diabetes, LifeScan, Novo Nordisk, Sanofi, Research Support; Self; Abbott, Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Lexicon Pharmaceuticals, Inc., Livongo, Medtronic, Medtrum Technologies, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker's Bureau; Self; BD, Medtronic, Sanofi. J. Westerbacka: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. C. Nicholls: Employee; Self; Sanofi. J. Gill: Employee; Self; Sanofi US, Other Relationship; Self; American Diabetes Association, Stock/Shareholder; Self; Sanofi US. M. Jones s: None. L. Shenoy: None. Funding: Sanofi [ABSTRACT FROM AUTHOR]

Aims: To better understand outcomes in people with type 2 diabetes at high risk of hypoglycemia, we conducted post hoc analyses in subgroups of participants from the real-world ACHIEVE Control study (NCT02451137) with ≥1 hypoglycemia risk factor.Methods: Insulin-naive adults with type 2 diabetes and A1c ≥8% were randomized 1:1 to insulin glargine 300 U/mL (Gla-300) or standard-of-care basal insulin (SOC-BI). Participants had documented history of ≥1 risk factors for hypoglycemia: chronic kidney disease, cardiovascular disease, dementia or blindness, age ≥65 years, or history of hypoglycemia. Outcomes included individualized A1c target attainment without documented symptomatic hypoglycemia (blood glucose [BG] ≤3.9 mmol/L or <3.0 mmol/L) or severe hypoglycemia, A1c target attainment, and absence of documented symptomatic or severe hypoglycemia at 6 and 12 months.Results: Within subgroups, odds ratios generally showed trends favoring Gla-300 versus SOC-BI, particularly for hypoglycemia avoidance in participants ≥65 years of age (BG ≤3.9 mmol/L; odds ratio, 1.52; 95% confidence interval, 1.14-2.03) and those with chronic kidney disease (BG ≤3.9 mmol/L; odds ratio, 2.28; 95% confidence interval, 1.26-4.12). Results were consistent with the overall population.Conclusions: These data suggest potential benefit of Gla-300 versus SOC-BI for avoiding hypoglycemia in participants with ≥1 hypoglycemia risk factor. [ABSTRACT FROM AUTHOR]

The outside back cover image is based on the Original Article A pragmatic randomized clinical trial of insulin glargine 300 U/mL versus first‐generation basal insulin analogues in insulin‐naïve adults with type 2 diabetes: 6‐month outcomes of ACHIEVE Control by Luigi F. Meneghini et al., https://doi.org/10.1111/dom.14152. [ABSTRACT FROM AUTHOR]

In the 12-month ACHIEVE Control study, significantly more insulin-naive patients with T2D treated with Gla-300 vs. SOC-BI (glargine 100 U/mL or detemir) achieved the primary composite endpoint of individualized HEDIS A1c target attainment at 6 months without documented symptomatic (≤70 mg/dL) or severe hypoglycemia. This post-hoc analysis explored outcomes in subgroups with estimated glomerular filtration rate (eGFR) of <60, 60 to <90, and ≥90 mL/min/1.73 m2. Patients with eGFR <60 mL/min/1.73 m2 were older and had longer T2D duration. Within each eGFR subgroup, baseline characteristics were generally balanced between treatment groups. Within subgroups, odds ratios for clinical outcomes generally showed trends favoring Gla-300 vs. SOC-BI, consistent with the overall study population (Figure). In patients with eGFR <60 mL/min/1.73 m2, the odds ratio point estimates for absence of documented symptomatic (≤70 mg/dL and <54 mg/dL) or severe hypoglycemia at 6 and 12 months strongly favored Gla-300 (>1.40). The results suggest a potential benefit of Gla-300 vs. SOC-BI for avoiding hypoglycemia in patients with compromised renal function that warrants further evaluation in prospective studies. Disclosure: L. Meneghini: Advisory Panel; Self; Novo Nordisk Inc., Sanofi US. Consultant; Self; Applied Therapeutics, Sanofi US. A. Cheng: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Applied Therapeutics, Sanofi. Speaker's Bureau; Self; Abbott, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Boehringer Ingelheim International GmbH, Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., mdBriefCase, Medtronic, Merck & Co., Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. P. Evenou: Employee; Self; Sanofi. J. Gill: Other Relationship; Self; Sanofi US. A. Mohamed: None. G.E. Umpierrez: None. Funding: Sanofi US [ABSTRACT FROM AUTHOR]