The OPT2MISE Study - A Review of the Major Findings and Clinical Implications.

Many patients with type 2 diabetes struggle to achieve adequate glucose control despite escalation of therapy including complex insulin regimens with multiple daily injections (MDIs). Previous randomised controlled trials failed to show a significant improvement in glycaemic control with pump therapy over multiple injections. The OPT2MISE study enrolled 495 adult patients with poorly controlled type 2 diabetes despite an intensified insulin regimen using rapid and slow-acting insulin analogues. After a 2-month run-in period, patients were randomised to switch to pump therapy or to maintain their MDI regimen. After 6 months, patients with pump therapy achieved a better glycaemic control than those who used multiple injections (glycated haemoglobin [HbA] difference of -0.7 %), and twice as many patients reached the target range of 8 % or less in the pump-therapy group compared with the injection group. Patients using pump therapy had a 20 % reduction of their total daily insulin dose. A moderate weight gain was observed with both treatments, and no severe hypoglycaemia nor ketoacidosis occurred in the pump therapy group. Pump therapy may now be considered as a valuable option in type 2 diabetes patients who fail to respond to an intensified insulin regimen.