BRIGHT demonstrated similar HbA1c reduction and hypoglycemia risk with the second-generation basal insulin analogs insulin glargine 300 U/mL (Gla-300) and insulin degludec 100 U/mL (IDeg) over 24 weeks, and less anytime (24 h) hypoglycemia with Gla-300 during the first 12 weeks, in T2DM. This analysis examined HbA1c change and confirmed (≤70 mg/dL and <54 mg/dL) hypoglycemia by baseline characteristics.
BRIGHT was a multicenter, open-label, randomized, active-controlled, parallel-group trial in T2DM. Participants receiving multiple oral agents ± GLP-1 RAs were randomized to Gla-300 (N=466) or IDeg (N=463), titrated to a fasting SMPG of 80-100 mg/dL.
Efficacy and safety with Gla-300 vs. IDeg were unaffected by age (≥65 years), gender, BMI category (<30/30-35/≥35 kg/m2) or diabetes duration (≥10 years). However, significant heterogeneity of treatment effect across subgroups (p=0.015) suggested greater HbA1c reduction with Gla-300 than IDeg with impaired renal function (eGFR <60 mL/min/1.73 m2) (Table), with no difference in hypoglycemia incidence or rates. Further analyses revealed lower confirmed (≤70 mg/dL) hypoglycemia rates with Gla-300 vs. IDeg in those with normal renal function, with comparable HbA1c reduction (Table).
In conclusion, Gla-300 appears to confer advantages vs. IDeg in those with impaired renal function, warranting further investigation.
M. Haluzik: Advisory Panel; Self; AstraZeneca, Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Consultant; Self; Johnson & Johnson, Lilly Diabetes. Speaker's Bureau; Self; Novartis AG. A. Philis-Tsimikas: Advisory Panel; Self; AstraZeneca, Lilly Diabetes, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Dexcom, Inc., Glooko, Inc., National Institute of Diabetes and Digestive and Kidney Diseases. Stock/Shareholder; Spouse/Partner; Ionis Pharmaceuticals, Inc., Novo Nordisk Inc. Z. Bosnyak: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. D. Müller-Wieland: Advisory Panel; Self; Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH. Speaker's Bureau; Self; Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH. F. Lauand: Employee; Self; Sanofi. L. Melas-Melt: Consultant; Self; Sanofi. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck & Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. G.B. Bolli: Advisory Panel; Self; Sanofi. Research Support; Self; A. Menarini Diagnostics, Medtronic.