Oral Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2014

New Insulin Glargine 300 U/mL: Glycaemic Control and Hypoglycaemia in Insulin Naïve People with T2DM (EDITION 3) (#94)

Matthew Riddle 1 , Richard Bergenstal 2 , Monika Zieman 3 , Kastytis Sestakauskas 4 , Stephen Twigg 5 , Harmonie Goyeau 6 , Philip Home 7 , Geremia Bolli 8
  1. Oregon Health and Science University, Portland, OR, USA
  2. International Diabetes Centre, Park Nicollet, MN, USA
  3. Sanofi, Frankfurt, Germany
  4. Sanofi, Chilly Mazarin, France
  5. Dept of Endocrinology, Royal Prince Alfred Hospital and Sydney Medical School, The University of Sydney, NSW, Australia
  6. Experis IT, Nanterre, France
  7. Newcastle University, Newcastle upon Tyne, UK
  8. University of Perugia, Perugia, Italy

EDITION 3 studied the efficacy and safety of new insulin glargine (300 U/mL; Gla-300) vs glargine 100 U/mL (Gla-100) in T2DM uncontrolled by treatments other than insulin.

In this 6-month, multicenter, open-label study participants (n=878, BMI 33 kg/m2, T2DM duration 9.8 yr, HbA1c 8.5 %) were randomised to once-daily Gla-300 or Gla-100 in the evening while stopping sulfonylureas. Insulin was titrated seeking fasting self-measured plasma glucose of 4.4–5.6 mmol/L. Primary endpoint was HbA1c change 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.

HbA1c decreased similarly with both treatments (LS mean change [SD] -1.42 [0.05] and -1.46 [0.05] % difference 0.04 [95% CI: -0.09 to 0.17] %). RR of experiencing any confirmed or severe nocturnal hypoglycaemia with Gla-300 vs Gla-100 was 0.76 [CI: 0.59 to 0.99] for the 6 month treatment. Rates (per patient-yr) of confirmed or severe events at any time were lower with Gla-300 (RR 0.75 [CI: 0.57 to 0.99]) over 6 months. Severe hypoglycaemia was infrequent in both treatment groups. 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.

In conclusion, in insulin naïve people with T2DM, Gla-300 provides comparable effective glycaemic control with less hypoglycaemia vs Gla-100.

Funding: Study sponsored by sanofi (NCT01676220).