[What has the largest study in the history of diabetology brought us?].

UNLABELLED

The main objective of the ORIGIN study was an observation of the effects of treatment with insulin analogue, insulin glargine on cardiovascular complications in patients with severe atherosclerosis and early stages of well-compensated diabetes and prediabetes. The authors expected that a long-term reduction of glycaemia on an empty stomach will reduce the number of occurrences of cardiovascular complications. The study, which was conducted over a period of more than six years, showed neither a positive nor a negative effect of insulin treatment on cardiovascular complications. The second main objective of the study was the following: to compare the effect of the omega-3 fatty acid treatment versus placebo on the development of cardiovascular complications. However, no influence of n-3 fatty acids on the development of cardiovascular complications was found. The study investigated whether the insulin glargine treatment leads to an increased number of cancer occurrences. No correlation between cancer and the insulin glargine treatment was proven in this study. Long-term insulin treatment in the early stages of diabetes led to a minimal increase in weight through the course of six years (1.5 kg) and to three times more hypoglycaemia occurrences compared to placebo. However, the number of hypoglycaemia occurrences was very small.

CONCLUSION

The study has confirmed the safety of the insulin glargine treatment combined with metformin in the early stages of diabetes, without an increased number of atherosclerosis or cancer occurrences, and with minimal weight gain.