ACHIEVE Control demonstrated superiority of Gla-300 vs. standard of care (SOC) BIs (glargine 100 U/mL and detemir), with a significantly greater proportion of insulin-naive T2D pts treated with Gla-300 achieving the composite primary endpoint of individualized HEDIS A1C targets at 6 months without severe and/or symptomatic documented hypoglycemia (blood glucose [BG] ≤70 mg/dL). Here we report outcomes in pts with and without CVD at baseline (BL). Characteristics at BL were generally well balanced between treatments, with a potential difference in GLP-1 receptor agonist use in CVD pts. In pts without CVD, outcomes consistently favored Gla-300 (Table). In CVD pts, composite endpoint attainment at 12 months was similar with Gla-300 and SOC-BI, while avoidance of hypoglycemia, especially serious hypoglycemia (BG <54 mg/dL), showed a trend favoring Gla-300 (Table); changes in A1C from BL to 12 months with Gla-300 and SOC-BI were similar (LS mean difference [95% CI] 0.12% [-0.12 to 0.35]; p=0.34). The results of this analysis are promising and warrant further exploration of the possibility that the more stable action profile of Gla-300 translates to T2D patients with CVD experiencing serious hypoglycemia less often with Gla-300 than first-generation BIs.
J.P. Frias: Advisory Panel; Self; Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Sanofi. Consultant; Self; Echosens, Genentech, Inc., Johnson & Johnson Diabetes Institute, Novo Nordisk Inc., Zafgen, Inc. Research Support; Self; AbbVie Inc., Akcea Therapeutics, Allergan, Amgen Inc., AstraZeneca, Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Cirius Therapeutics, Elcelyx Therapeutics, Inc., Eli Lilly and Company, Enanta Pharmaceuticals, Inc., GENFIT, Intarcia Therapeutics, Inc., Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., NGM Biopharmaceuticals, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Oramed Pharmaceuticals, Pfizer Inc., Sanofi, TaiwanJ Pharmaceuticals Co., Ltd., Theracos, Inc. Speaker’s Bureau; Self; Merck & Co., Inc., Sanofi. P. Evenou: Employee; Self; Sanofi US. D. Dalton: Employee; Self; Sanofi US. K.M. Dungan: Advisory Panel; Self; Eli Lilly and Company, Elsevier, Sanofi-Aventis. Research Support; Self; Eli Lilly and Company, GlaxoSmithKline plc., Novo Nordisk Inc., Sanofi-Aventis, Viacyte. Other Relationship; Self; DKBmed, UpToDate.