The Copenhagen Insulin and Metformin Therapy Trial

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.

Conditions

• Type 2 Diabetes
• Atherosclerosis
• Arteriosclerosis

Interventions

DRUG

metformin

metformin tablets 2 g x 2

DRUG

insulin detemir

insulin as requested

DRUG

insulin aspart + insulin aspart protamin

insulin as requested

DRUG

Insulin aspart

insulin as requested

Sponsors & Collaborators

• Hvidovre University Hospital

  collaborator OTHER

• Hillerod Hospital, Denmark

  collaborator OTHER

• Frederiksberg University Hospital

  collaborator OTHER

• University Hospital, Gentofte, Copenhagen

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Novo Nordisk A/S

  collaborator INDUSTRY

• Steno Diabetes Center Copenhagen

  lead OTHER

Principal Investigators

• Thomas Almdal, MD DMSc · Hvidovre University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2012-12-31

Completion

2012-12-31

Countries

• Denmark

Study Locations