Overview

Detemir Energy Expenditure Study

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Surrey
Collaborator:
Novo Nordisk A/S
Treatments:
Insulin
Insulin, Isophane
Isophane insulin, beef
Isophane Insulin, Human
Criteria
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.