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.

graphic
View largeDownload slide
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.

© 2018 by the American Diabetes Association.
2018
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.