Detemir Energy Expenditure Study

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Obesity
• Interventions: Drug: Insulatard; Drug: Detemir

• Registration Number: NCT00788840
• Lead Sponsor: University of Surrey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-11
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Insulatard	Insulatard	-
2. Detemir	Detemir	-

Primary Outcome Measures

Name	Time	Method
Weight change	6 months

Secondary Outcome Measures

Name	Time	Method
Glycaemic control	6 months
Energy Expenditure	6 months
Fat & muscle gene expression	6 months
Fat composition	6 months

Trial Locations

Locations (1)

Cedar Centre, Royal Surrey County Hospital; 🇬🇧 Guildford, Surrey, United Kingdom