Guidelines emphasize achieving glycemic targets without hypoglycemia. BRIGHT demonstrated similar HbA1c reduction and less anytime (24 h) hypoglycemia with insulin glargine 300 U/mL (Gla-300) vs. insulin degludec 100 U/mL (IDeg) during the initial 12-week insulin titration period, in insulin-naïve adults with T2DM. We investigated achievement of ADA-recommended HbA1c and fasting self-monitored plasma glucose (FSMPG) targets without confirmed (≤70 mg/dL) hypoglycemia in the first 12 weeks.

BRIGHT was a 24-week, multicenter, open-label, randomized, active-controlled, parallel-group, phase 4 trial. Participants were randomized to Gla-300 (n=466) or IDeg (n=463), titrated to a FSMPG of 80-100 mg/dL (below ADA-recommended FSMPG target of ≤130 mg/dL).

A similar proportion of participants at week 8 achieved HbA1c <7% without hypoglycemia in both groups; this proportion was numerically higher with Gla-300 than IDeg at week 12 (16.9% vs. 13.6%). From baseline to week 5, numerically more patients with IDeg achieved FSMPG ≤130 mg/dL without hypoglycemia vs. Gla-300, but from week 6 to 12 this was reversed (Figure). More participants achieved ADA-recommended glycemic targets without hypoglycemia with Gla-300 vs. IDeg during the titration period of BRIGHT. These second-generation basal insulin analogs may allow more aggressive titration after insulin initiation in T2DM.

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Disclosure

R. Roussel: Advisory Panel; Self; Merck Sharp & Dohme Corp., Sanofi. Consultant; Self; Abbott, AstraZeneca, Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Physiogenex. Research Support; Self; Janssen Pharmaceuticals, Inc. 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. J. Westerbacka: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. Z. Bosnyak: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. L. Melas-Melt: Consultant; Self; Sanofi. L. Berard: Advisory Panel; Self; Eli Lilly and Company. Consultant; Self; Abbott, Ascensia Diabetes Care, AstraZeneca, Bayer AG, Becton, Dickinson and Company, Janssen Pharmaceuticals, Inc., LifeScan Canada, Mylan, Novo Nordisk Inc., Sanofi. Research Support; Self; Montmed Inc. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc. A.Y. Cheng: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Boehringer Ingelheim International GmbH, Sanofi. Speaker's Bureau; Self; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., mdBriefCase Group Inc., Merck & Co., Inc., Novo Nordisk A/S, Sanofi.

Funding

Sanofi (NCT02738151)

© 2019 by the American Diabetes Association.
2019
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