Detemir Energy Expenditure Study (DEES)

University of Surrey

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus; Obesity

Treatments: Drug: Detemir; Drug: Insulatard

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00788840

EC/2008/14/FHMS

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

1. Insulatard

Active Comparator group

Treatment:

Drug: Insulatard

2. Detemir

Active Comparator group

Treatment:

Drug: Detemir