The effect of insulin detemir on energy balance, postprandial nutrient handling, body fat distribution,and adipose tissue metabolism and gene expression in patients with type 2 diabetes. - Metabolic Effects of Detemir
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 9.1 Level: LLT Classification code 10053247 Term: Insulin-requiring type 2 diabetes mellitus
- Registration Number
- EUCTR2007-003085-17-GB
- Lead Sponsor
- niversity of Surrey
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
1. Informed consent
2. Type 2 diabetes mellitus
3. Treated with metformin
4. Already on treatment with twice-daily NPH insulin with or without short-acting insulin or a 'basal-bolus' regimen
5. Above 18 years of age
6. BMI 27-35
7. Able and willing to perform own blood glucose monitoring
8. Able and willing to maintain consistent eating habits throughout the entire study period
9. Able and willing to maintain consistent physical activity throughout the entire study period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Patients on sulphonylureas or thiazolidinediones
2. Proliferative retinopathy that has required acute treatment in the last 6 months
3. Impaired hepatic or renal function
4. Cardiac problems
5. Uncontrolled hypertension
6. Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation
7. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method