Sanofi-aventis has launched a major research programme 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. The research will contribute to the scientific resolution of the debate over insulin safety, including insulin analogs and Lantus (insulin glargine).

This matter has been the subject of extensive discussion and debate within the scientific and medical communities for many years. 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, as was communicated by the company earlier this year.

The company's scientific plan covers state-of-the-art pre-clinical and clinical programs 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, that will be conducted across Europe and North America. The plan is structured to yield short-term and longer-term results.

"We know that patients, physicians and the medical community 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, stated Dr Jean-Pierre Lehner, chief medical officer, Sanofi-aventis.

Sanofi-aventis' scientific 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.

Patient safety is and has always been the primary concern of sanofi-aventis. Sanofi-aventis has 80 years of experience in the development of insulins and stands behind the safety of Lantus. Extensive data involving over 70,000 patients in clinical studies, including randomized, controlled clinical trials that represent the gold standard of evidence, and the results of post-marketing surveillance arising from 24 million patient-years of clinical experience do not indicate an association between Lantus and cancer.