The Copenhagen Insulin and Metformin Therapy Trial
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Type 2 Diabetes Mellitus patients (T2DM) have an increased mortality rate due to
macrovascular disease. The primary objective of the study is to evaluate the effect of an
18-month treatment with metformin versus placebo in combination with one of three insulin
analogue regimens following a treat-to-target principle. The primary outcome measure is
change in wall thickness of the carotic arteries(CIMT)measured by ultrasound. A total of 900
patients with T2DM and HbA1c above 7.5% will be included.
Phase:
Phase 4
Details
Lead Sponsor:
Steno Diabetes Center Steno Diabetes Center Copenhagen
Collaborators:
Bispebjerg Hospital Copenhagen Trial Unit, Center for Clinical Intervention Research Frederiksberg University Hospital Herlev Hospital Hillerod Hospital, Denmark Hvidovre University Hospital Novo Nordisk A/S Rigshospitalet, Denmark University Hospital Koge University Hospital, Gentofte, Copenhagen Zealand University Hospital