Diabetologie und Stoffwechsel 2015; 10 - P172
DOI: 10.1055/s-0035-1549678

New insulin glargine 300 U/mL: glycaemic control and hypoclycaemia in insulin-naïve people with type 2 diabetes mellitus (EDITION 3)

M Ziemen 1, MC Riddle 2, RM Bergenstal 3, K Sestakauskas 4, H Goyeau 5, PD Home 6, GB Bolli 7
  • 1Sanofi Aventis Deutschland GmbH, Frankfurt am Main, Germany
  • 2Oregon Health & Science University, Portland, United States
  • 3International Diabetes Center at Park Nicollet, Minneapolis, United States
  • 4Sanofi, Chilly Mazarin, France
  • 5EXPERIS IT, Nanterre, France
  • 6Newcastle University, Newcastle upon Tyne, United Kingdom
  • 7University of Perugia, Perugia, Italy

Background and aims: EDITION 3 studied the efficacy and safety of new insulin glargine 300 U/mL (U300) vs. glargine 100 U/mL (Gla-100) in people with type 2 diabetes mellitus uncontrolled on non-insulin therapy.

Materials and Methods: 6-month, multicenter, open-label study; participants randomized to once-daily Gla-300 or Gla-100 in the evening while stopping sulfonylureas. Insulin was titrated seeking fasting SMPG 4.4 – 5.6 mmol/L (80 – 100 mg/dL). Primary endpoint was HbA1c change from baseline to month 6. Main secondary endpoint was percentage of participants with ≥1 confirmed (≤3.9 mmol/L (≤70 mg/dL)) or severe nocturnal hypoglycaemic event from week 9 to month 6.

Results: 878 participants randomized (baseline characteristics: BMI 33.0 kg/m2; diabetes duration 9.8 years; HbA1c 8.5%). HbA1c decreased similarly with both treatments (LS mean changes (SE) U300: -1.42 (0.05)%; U100: -1.46 (0.05)%. Relative risk of experiencing ≥1 confirmed (≤3.9 mmol/L (≤70 mg/dL)) or severe nocturnal hypogycaemic event with Gla-300 vs. Gla-100 was 0.76 (95% CI: 0.59 to 0.99) for the 6-month treatment period, 0.74 (0.48 to 1.13) for baseline to week 8, and 0.89 (0.66 to 1.20) (p = 0.45) for week 9 to month 6 (main secondary endpoint). Mean weight change was +0.4 (SD 3.8)kg with Gla-300 and +0.7 (3.8)kg with Gla-100. No differences in adverse events were seen.

Conclusion: In insulin-naïve people with type 2 diabetes, new insulin glargine 300 U/mL provides comparable effective glycemic control, with less hypoglycemia, compared with glargine 100 U/.

Study was sponsored by Sanofi