NewInsulinGlargine300Units/mL Versus Glargine 100 Units/mL in People With Type 2 Diabetes Using Basal andMealtimeInsulin:Glucose Control and Hypoglycemia in a 6-Month Randomized Controlled

To compare 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. RESEARCH DESIGN AND METHODS EDITION 1 (NCT01499082) 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. RESULTS Participants (n = 807) hadmean age 60 years, diabetes duration 16 years, BMI 36.6 kg/m2, and HbA1c 8.15 % (65.6 mmol/mol). HbA1c reduction was equivalent be-tween 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 con-firmed (£3.9 mmol/L) or severe nocturnal hypoglycemic events between week 9 andmonth 6with 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. CONCLUSIONS 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