Trials / Completed
CompletedNCT00862875
Levemir-Body Composition and Energy Metabolism
Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Institut de Recherches Cliniques de Montreal · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Detemir or Glargine | Initial dose of 10 units of insulin at bedtime. The insulin dose will be increase by 1 unit per day until fasting plasma glucose (FPG) levels are 5.0 mmol/L. |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2014-04-01
- First posted
- 2009-03-17
- Last updated
- 2014-05-07
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00862875. Inclusion in this directory is not an endorsement.