Poster 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 a Meta-analysis of Phase 3a EDITION Clinical Trials in People with T2DM (#328)

Ronan Roussel 1 , Geremia Bolli 2 , Laetitia Vinet 3 , Hannele Yki-Jarvinen 4 , Stephen Twigg 5 , Robert Ritzel 6
  1. Bichat Hospital, Paris, France
  2. University of Perugia, Perugia, Italy
  3. Sanofi, Chilly Mazarin, France
  4. University of Helsinki, Helsinki, Finland
  5. Dept of Endocrinology, Royal Prince Alfred Hospital and Sydney Medical School, The University of Sydney, NSW, Australia
  6. Municipal Hospital Munich, Munich, Germany

The EDITION 1, 2 and 3 studies compared the efficacy and safety of new insulin glargine 300 U/mL (Gla-300) with insulin glargine 100 U/mL (Gla-100) in people with T2DM on basal and mealtime insulin, basal insulin and OADs, and no prior insulin, respectively.

A meta-analysis of these three studies enabled glycaemic control and hypoglycaemia to be examined over 6 months in a large, heterogeneous T2DM population (Gla-300, N=1247; Gla-100, N=1249). Mean change in HbA1c was comparable for Gla-300 and Gla-100 (each −1.02 [SE 0.03] %). Gla-300 was associated with a reduced risk of experiencing a hypoglycaemic event vs Gla-100 (nocturnal and at any time of day; Table).

Rates of nocturnal hypoglycaemia were consistently lower with Gla-300 than Gla-100. Severe hypoglycaemia at any time of the day was rare in both treatment groups (2.3% with Gla-300 vs 2.6% with Gla-100). Weight gain with Gla-300 and Gla-100 was slight (mean change: 0.49 [SE 0.10] kg, 0.75 [0.10] kg, respectively), with a trend for less weight gain with Gla-300 (−0.26 [95% CI −0.52 to 0.01] kg, p=0.058).

In conclusion, Gla-300 provides comparable glycaemic control to Gla-100 in T2DM, with consistently less hypoglycaemia at any time of the day and less nocturnal hypoglycaemia.