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

Clinical Trials in the New Insulin Glargine 300 U/mL in Type 2 Diabetes (#188)

Stephen Twigg 1 2
  1. Charles Perkins Centre and Sydney Medical School, University of Sydney, Sydney, NSW, Australia
  2. Diabetes Centre, Dept of Endocrinology, Royal Prince Alfred Hospital, Sydney, NSW , Australia

The new insulin glargine 300U/mL (Gla-300) confers flatter and more extended PK/PD profiles with prolonged and tighter blood glucose (BG) control than insulin glargine 100U/ml (Gla-100), and with evenly distributed 24h coverage at a clinically relevant dose of 0.4 U/kg.

The EDITION (1 to 3) clinical trials phase 3a program has recently examined Gla-300 as therapy in adult patients with type 2 diabetes on basal and mealtime insulin therapy, basal insulin and OADs, or on no prior insulin, respectively, each addressing efficacy and safety, for at least 6 months. This presentation will report upon this series of studies, individually and by meta-analysis in a total of more than 2,400 subjects, showing evidence that relative to Gla-100, Gla-300 reduces nocturnal and total hypoglycaemia events whilst it provides comparable improved chronic glycaemic control based on HbA1c levels and fasting plasma glucose. Severe hypoglycemia was rare in both treatment groups. A trend to less body weight gain for Gla-300 compared with Gla-100 was also observed. No between-treatment differences in adverse events were seen.

Collectively, the EDITION clinical trial series suggests that Gla-300 may become the preferred insulin glargine preparation for people with type 2 diabetes.

The presenter is a member of an international Advisory Board of Gla-300 (Sanofi-Aventis).