Similar Glycemic Control and Less or Comparable Hypoglycemia with Insulin Glargine 300 U/mL (Gla-300) vs. Degludec 100 U/mL (IDeg-100) in Insulin-Naïve T2DM on Antihyperglycemic Drugs ± GLP-1 RAs—The BRIGHT Randomized Study
Authors: CHENG ALICE Y.Y. , ROSENSTOCK JULIO , RITZEL ROBERT , BOSNYAK ZSOLT , DEVISME CHRISTINE , STELLA PETER , CALI ANNA M. , WANG XIANGLING , FRIAS JUAN P. , ROUSSEL RONAN , BOLLI GEREMIA B. 
Published: June 2018

BRIGHT is the first head-to-head clinical trial investigating the efficacy and safety of Gla-300 vs. IDeg-100. In this 24-week, multinational, open-label, parallel-group, treat-to-target trial (NCT02738151), 929 insulin-naïve T2DM adults (mean HbA1c, 8.6%; DM duration, 10.6 years; BMI, 31.5 kg/m2), inadequately controlled with oral antihyperglycemic drugs ± GLP-1 RAs, were randomized 1:1 to once-daily Gla-300 or IDeg-100. Primary endpoint: HbA1c change from baseline to week 24. Secondary endpoints included hypoglycemia, blood glucose levels, and adverse events. Non-inferiority of Gla-300 vs. IDeg-100 was demonstrated for the primary endpoint (Table). Gla-300 had similar fasting SMPG reduction to IDeg-100 (Table), with final daily insulin doses of 0.54 and 0.43 U/kg from starting evening doses, per label, of 0.2 U/kg and 10 U/day (0.12 U/kg), respectively. Over the 24-week period, incidence of confirmed (≤70 mg/dL) or severe hypoglycemia was comparable, but event rates were lower with Gla-300 vs. IDeg-100, by 14% at any time of day (24h) and 19% at night (00:00-05:59 h) (Table).

In summary, BRIGHT showed that Gla-300 provides similar glycemic control to IDeg-100, with less or comparable hypoglycemia, in previously inadequately controlled, insulin-naïve adults with T2DM.

Disclosure

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