Detemir Energy Expenditure Study

Obesity Clinical Trial

— DEES  

Official title:

A 24-week, National, Single-centre, Open-labelled, Randomised, Parallel-group Trial Comparing Energy Expenditure With Insulin Detemir Versus NPH Insulin Using a Basal-bolus Regimen With Insulin Aspart as the Mealtime Insulin in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788840
• Other study ID #: EC/2008/14/FHMS
• Status: Completed
• Phase: Phase 4
• Start date: January 2008
• Est. completion date: August 2009

Study information

• Verified date: May 2023
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulatard
Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.
• Detemir
Detemir insulin used as long-acting insulin in treatment phase of study.

Locations

Country	Name	City	State
United Kingdom	Cedar Centre, Royal Surrey County Hospital	Guildford	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
University of Surrey	Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change		6 months
Secondary	Energy Expenditure		6 months
Secondary	Fat composition		6 months
Secondary	Fat & muscle gene expression		6 months
Secondary	Glycaemic control		6 months