Type 2 Diabetes Mellitus, Obesity
Conditions
Brief summary
This is a study designed to compare the effects of 2 long-acting insulins, detemir and insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic control and fat and muscle gene expression over a 6 month period.
Interventions
DRUGInsulatard
Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.
DRUGDetemir
Detemir insulin used as long-acting insulin in treatment phase of study.
Sponsors
Novo Nordisk A/S
University of Surrey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes 2. Treated with metformin 3. Already on treatment with a long-acting or intermediate insulin. 4. Over 18 years of age, 5. HbA1c \> 7.0% 6. BMI 27-40 7. Able and willing to perform self-blood glucose monitoring. 8. Able and willing to maintain consistent eating habits throughout the entire trial period. 9. Able and willing to maintain consistent physical activity level during the entire trial period
Exclusion criteria
1. Patients on sulphonylureas or thiazolidinediones 2. Proliferative retinopathy that has required acute treatment within the last six months. 3. Impaired hepatic or renal functions. 4. Cardiac problems. 5. Uncontrolled hypertension (treated or untreated). 6. Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight change | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Energy Expenditure | 6 months |
| Fat composition | 6 months |
| Fat & muscle gene expression | 6 months |
| Glycaemic control | 6 months |
Countries
United Kingdom
Outcome results
None listed