Sanofi-Aventis has unveiled plans for a major research programme which will look at any potential link between insulin treatments, notably its own diabetes drug Lantus, and cancer.

The French drugmaker says it is going to undertake “methodologically robust research” that will contribute to “the scientific resolution of the debate over insulin safety, including insulin analogues and Lantus (insulin glargine)". Sanofi adds that “this matter has been the subject of extensive discussion and debate within the scientific and medical communities for many years”.

It was certainly a topic for discussion this summer after three of four studies, published in the journal Diabetologia suggested an increased risk for cancer, especially breast cancer associated with use of Lantus. Sanofi disagreed with those findings, issuing a statement prepared by “a multidisciplinary board of renowned international experts” who said the studies were “inconclusive and inconsistent”. The European Medicines Agency which says that the “available data does not provide a cause for concern.

However, Sanofi says that “while there is a consensus among leading scientists around the world regarding the difficulties of developing conclusive evidence”, it is “committed to exploring this matter in depth”. The company is therefore introducing a scientific plan that will “encompass state-of-the-art pre-clinical and clinical programmes involving human insulin and insulin glargine”. These include a case-control study of recent breast cancer comparing glargine to other insulins, to be conducted in Europe and North-America.

Jean-Pierre Lehner, Sanofi’s chief medical officer, said the plan, “which we are currently implementing, will generate robust data that will help add to the assessment of any insulin’s and Lantus’ safety.”