Similar Variability of Fasting and 24-h Self-Measured Plasma Glucose (SMPG) with Insulin Glargine 300 U/mL (Gla-300) vs. Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve Adults with T2DM—The Randomized BRIGHT Trial

Abstract

BRIGHT was an open-label, randomized, parallel-group, 24-week study in insulin naïve participants with uncontrolled T2DM, investigating efficacy and safety of Gla-300 and IDeg-100. Participants were randomized to Gla-300 or IDeg-100, titrated to a target fasting SMPG of 80-100 mg/dL. The primary objective (non-inferiority of Gla-300 vs. IDeg-100 in HbA1c change from baseline to week 24) was met. Secondary endpoints, presented here, included change in variability of fasting and 24-h SMPG. Eight-point SMPG profiles were similar for both groups at week 24. Mean baseline coefficient of variation (CV) of ≥3 fasting SMPG measurements over 7 days was 13.73% and 14.63% for Gla-300 and IDeg-100, respectively. Change in fasting SMPG variability (SE) to week 24 was 1.49% (0.39) and 1.97% (0.39) for Gla-300 and IDeg-100 (least squares [LS] mean difference [95% CI] −0.48 [−1.49 to 0.53]) (Figure a). Mean baseline CVs for 8-point profiles (24-h SMPG) were 22.60% and 23.41% for Gla-300 and IDeg-100. Mean change in 24-h SMPG variability (SE) was 3.70% (0.59) and 3.95% (0.60) for Gla-300 and IDeg-100 at week 24 (LS mean difference −0.25 [−1.72 to 1.22]) (Figure b). In summary, Gla-300 and IDeg-100 had similar variability of fasting and 24-hour SMPG over the 24-week treatment period in BRIGHT. Disclosure A.Y.Y. Cheng: Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Abbott. Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Merck & Co., Inc.. Speaker's Bureau; Self; Merck & Co., Inc.. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Consultant; Self; Takeda Canada Inc.. Research Support; Self; Sanofi, Boehringer Ingelheim GmbH. R. Ritzel: Speaker's Bureau; Self; AstraZeneca. Consultant; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Consultant; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Consultant; Self; Servier. Speaker's Bureau; Self; Bristol-Myers Squibb Company, Merck Sharp & Dohme Corp., Boehringer Ingelheim GmbH, Eli Lilly and Company, Novartis Pharmaceuticals Corporation. Z. Bosnyak: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. E. Boelle-Le Corfec: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. A.M. Cali: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. X. Wang: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. J.P. Frias: Research Support; Self; AbbVie Inc., Allergan, Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company. Consultant; Self; CeQur Corporation. Research Support; Self; Cirius Therapeutics, AstraZeneca, Calibra Medical, Elcelyx Therapeutics, Inc.. Consultant; Self; Elcelyx Therapeutics, Inc.. Research Support; Self; Eli Lilly and Company, Genentech, Inc., Ionis Pharmaceuticals, Inc., ICON plc., Janssen Pharmaceuticals, Inc.. Consultant; Self; Johnson & Johnson Diabetes Institute, LLC.. Research Support; Self; Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc.. Consultant; Self; Ligand Pharmaceuticals, Inc.. Research Support; Self; Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Pfizer Inc., Sanofi. Consultant; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; Theracos, Inc. R. Roussel: Advisory Panel; Self; AbbVie Inc., Abbott, Eli Lilly and Company, Sanofi, Novo Nordisk A/S, AstraZeneca. Speaker's Bureau; Self; Servier. Consultant; Self; Bayer AG. Advisory Panel; Self; Merck Sharp & Dohme Corp.. Research Support; Self; Amgen Inc., Sanofi, Novo Nordisk A/S, Danone Research. Stock/Shareholder; Self; Iriade. Advisory Panel; Self; Physiogenex S.A.S. G.B. Bolli: Speaker's Bureau; Self; Menarini Group, Sanofi. Research Support; Self; Sanofi.