Status:
COMPLETED
Detemir Energy Expenditure Study
Lead Sponsor:
University of Surrey
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes Mellitus
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 mu...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- Treated with metformin
- Already on treatment with a long-acting or intermediate insulin.
- Over 18 years of age,
- HbA1c \> 7.0%
- BMI 27-40
- Able and willing to perform self-blood glucose monitoring.
- Able and willing to maintain consistent eating habits throughout the entire trial period.
- Able and willing to maintain consistent physical activity level during the entire trial period
Exclusion
- Patients on sulphonylureas or thiazolidinediones
- Proliferative retinopathy that has required acute treatment within the last six months.
- Impaired hepatic or renal functions.
- Cardiac problems.
- Uncontrolled hypertension (treated or untreated).
- Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00788840
Start Date
January 1 2008
End Date
August 1 2009
Last Update
May 31 2023
Active Locations (1)
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1
Cedar Centre, Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7XX