Sanofi-aventis launches major insulin safety research programme

French pharma company sanofi-aventis is to undertake an action plan to provide methodologically robust research that will contribute to the scientific resolution of the debate over insulin safety, including insulin analogues and Lantus (insulin glargine).

The research programme is designed to generate more information on whether there is any association between cancer and insulin use and to assess if there is any difference in risk between insulin glargine and other insulins. While there is a consensus among leading scientists around the world regarding the difficulties of developing conclusive evidence, sanofi-aventis is committed to exploring this matter in depth.

Sanofi-aventis' scientific plan will encompass state-of-the-art pre-clinical and clinical programmes involving human insulin and insulin glargine. Pre-clinical studies will assess the differential effects of insulin glargine, its metabolites and other insulins in various models. The clinical development plan is based on several rigorous epidemiological studies, designed and implemented with the support of international experts and institutions, and will be conducted across Europe and North America.

The programme and studies will be initiated in the coming weeks. Timelines for study completion and data generation will vary depending on each type of study. The plan is structured to yield short-term and longer-term results.

"Sanofi-aventis is committed to patients" safety," said Dr Jean-Pierre Lehner, chief medical officer, sanofi-aventis. "We know that patients, physicians and the medical community at large are looking forward to getting increased scientific knowledge on the matter. We believe that the plan that we are currently implementing will generate robust data that will help add to the assessment of any insulin's and Lantus" safety."