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.
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.