Sanofi-aventis announced results of a study which demonstrated that patients using Lantus (insulin glargine [rDNA origin] injection) once-daily and Apidra (insulin glulisine [rDNA origin] injection) before meals reported improved patient reported outcomes and decreased glycemic variability versus premix analog insulin. Two abstracts from this study were highlighted at the American Diabetes Association’s 70th Annual Scientific Sessions (ADA).

People following a basal-bolus insulin regimen use separate injections of a basal insulin and a mealtime insulin. This regimen is designed to address hyperglycaemia before it happens by providing adequate insulin to cover fasting and prandial insulin needs. A premix insulin regimen combines prandial insulin analogs and the intermediate-acting insulin, NPH, in one injection. The results of this study demonstrated that patients using a basal-bolus regimen, with Lantus and Apidra, reported improved outcomes and quality of life.

“These results indicate that patients treated with a basal-bolus insulin regimen consisting of Lantus and Apidra demonstrate an improved quality of life and patient reported outcomes compared to those treated with premix analog insulin,” said Donald Simonson, MD, MPH, ScD of the Endocrinology, Diabetes and Hypertension Division of Brigham and Women’s Hospital in Boston, Massachusetts and principal investigator of the study.

In this multi-centre, randomized clinical trial conducted in 52 US centres, 388 insulin treated patients (82 Type 1 diabetes, 306 Type 2 diabetes) were randomized to open-label daily Lantus and premeal Apidra (Lantus and Apidra; n=192) or twice-daily premix 75/25 or 70/30 (premix; n=196) for 12 weeks (Period 1) and crossed to an alternate arm for 12 weeks (Period 2) while being titrated to A1C of <7%. The baseline A1C was 7.8+/-0.7%.

Sanofi-aventis strives to be a 360 degree partner delivering innovative and integrated solutions for people living with diabetes. The company currently has insulin products, including Lantus, Apidra and Insuman -- Lantus and Apidra are also available as injection pens (Lantus SoloSTAR and Apidra SoloSTAR). Also available in some countries (outside the US) is ClikSTAR, a reusable insulin injection pen for Lantus or Apidra for people with type 1 or type 2 diabetes. Following the formation of its Diabetes Division, sanofi-aventis has agreements with other companies for the development of blood glucose monitoring solutions and the potential first regenerative treatment for diabetes. Investigational compounds also in the pipeline include a once-daily injectable GLP-1 agonist as a monotherapy and in combination with Lantus as well as a long-acting insulin analog.