A reduced risk of nocturnal hypoglycemia is among the advantages….
An international team of researchers conducted a trial as part of the multinational EDITION 1 study, comparing the efficacy and safety of new insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in people with type 2 diabetes on basal insulin (≥42 units/day) plus mealtime insulin. The U.S. Food and Drug Administration has accepted Sanofi’s New Drug Application for Gla-300, which it hopes to market as Toujeo.
The study was a 6-month, multinational, open-label, parallel-group study. Adults with glycated hemoglobin A1c (HbA1c) 7.0–10.0% (53–86 mmol/mol) were randomized to Gla-300 or Gla-100 once daily with dose titration seeking fasting plasma glucose 4.4–5.6 mmol/L. Primary end point was HbA1c change from baseline; main secondary end point was percentage of participants with one or more confirmed (≤3.9 mmol/L) or severe nocturnal hypoglycemia from week 9 to month 6.
Participants (n = 807) had mean age 60 years, diabetes duration 16 years, BMI 36.6 kg/m2, and HbA1c 65.6 mmol/mol (8.15%). HbA1c reduction was equivalent between regimens; least squares mean difference –0.00% (95% CI –0.11 to 0.11) (–0.00 mmol/mol [–1.2 to 1.2]). Fewer participants reported one or more confirmed (≤3.9 mmol/L) or severe nocturnal hypoglycemic events between week 9 and month 6 with Gla-300 (36 vs. 46% with Gla-100; relative risk 0.79 [95% CI 0.67–0.93]; P < 0.005); nocturnal hypoglycemia incidence and event rates were also lower with Gla-300 in the first 8 weeks of treatment. No between-treatment differences in tolerability or safety were identified.
The researchers found that Gla-300 controls HbA1c as well as Gla-100 for people with type 2 diabetes treated with basal and mealtime insulin, but with consistently less risk of nocturnal hypoglycemia.
- Insulin glargine 300U/ml (Toujeo) has a reduced risk of nocturnal hypoglycemia compared to insulin glargine 100U/ml (Lantus)
- Similar reductions of HbA1c levels in both Gla-300 and Gla-100
- Glargine molecule is unchanged so both Gla-300 and Gla-100 have the same tolerability and safety profiles
New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 2 Diabetes Using Basal and Mealtime Insulin: Glucose Control and Hypoglycemia in a 6-Month Randomized Controlled Trial (EDITION 1),
Published online before print July 30, 2014, doi: 10.2337/dc14-0991
Diabetes Care July 30, 2014