A Randomized Pragmatic Real-World Clinical Trial Comparing Insulin Glargine 300 U/mL (Gla-300) with Standard of Care First-Generation Basal Insulins (SoC-BIs) in Insulin-Naive Patients with Type 2 Diabetes: Twelve-Month Analysis of the ACHIEVE Control Study

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