Diabetes, Cancer Link Is New Research Focus
The other three studies show no statistically significant overall increased risk for glargine, nor did a subsequent analysis conducted by Sanofi-Aventis of its data from 31 clinical trials involving a combined population of 10,880 people with 5,657 on glargine. For all cancers, the rates were no different than in the general population. A further analysis from 26 uncontrolled trials also showed no indication of increased risk, said Dr. Skyler.
And one more source of data, the ongoing ORIGIN (Outcome Reduction With an Initial Glargine Intervention) study of more than 12,612 randomized subjects has also found no increased cancer risk in more than 50,000 patient-years of exposure, he added.
“The totality of the available evidence suggests that the headlines which suggested that 'Glargine Causes Cancer' are unsubstantiated, unwarranted, and unproven,” Dr. Skyler commented.
Dr. David Russell-Jones gave an overview of a new meta-analysis of safety data conducted by Novo-Nordisk for its long-acting insulin analogue, detemir. In studies lasting about 24 weeks, the risk for cancers of all types among 3,983 patients with either type 1 or type 2 diabetes on detemir was 0.36 per 1,000 person-years of exposure, compared with 0.92 for 2,661 similar patients using NPH insulin.
Those rates yielded an identical odds ratio of 2.53 using two different methods of statistical calculation, said Dr. Russell-Jones of the University of Surrey, England.
Dr. Gale, in his closing remarks, referred to Diabetologia as the “epicenter of the storm.” As a result, “many members of the medical community and the public have been confused, and in some cases angry. I think this has been one of the most difficult, confusing, emotive and controversial issues I have ever had to deal with.”
And while acknowledging that he had received some criticism for publishing the articles in the first place—given that they raised more questions about the glargine/cancer issue than they answered—Dr. Gale said he has no regrets or apologies, noting, “The answer to the question may well be negative, but the question has to be asked.”
Dr. Johnson declared he had participated as a speaker for Eli Lilly & Co. Dr. Gale, Dr. Smith, and Dr. Currie stated they had no conflicts of interest. Both Dr. Skyler and Dr. Russell-Jones declared financial relationships with other diabetes-related companies in addition to the ones they were representing at the symposium.
In September, Sanofi-Aventis announced the launch of a research program to investigate whether there is a relationship between cancer and insulin use, including the analogues.
'The answer to the question may well be negative, but the question has to be asked.'
Source DR. GALE
Some of the cancer risk was attenuated in those using metformin with insulin.
Source DR. CURRIE
