Trials / Completed
CompletedNCT00657943
The Copenhagen Insulin and Metformin Therapy Trial
The Effect of Metformin Versus Placebo, Including Three Insulin-Analogue Regimens With Variating Postprandial Glucose Regulation, on CIMT in T2DM Patients - A Randomized, Multicenter Trial
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 415 (actual)
- Sponsor
- Steno Diabetes Center Copenhagen · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2008-04-14
- Last updated
- 2014-02-04
Locations
9 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00657943. Inclusion in this directory is not an endorsement.