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DEES: Detemir Energy Expenditure Study

Sponsor
University of Surrey (Other)
Overall Status
Unknown status
CT.gov ID
NCT00788840
Collaborator
Novo Nordisk A/S (Industry)
30
Enrollment
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Jan 1, 2008
Anticipated Primary Completion Date :
Aug 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1. Insulatard

Drug: Insulatard
Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.
Active Comparator: 2. Detemir

Drug: Detemir
Detemir insulin used as long-acting insulin in treatment phase of study.
Other Names:
  • Levemir

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Weight change [6 months]

    Secondary Outcome Measures

    1. Energy Expenditure [6 months]

    2. Fat composition [6 months]

    3. Fat & muscle gene expression [6 months]

    4. Glycaemic control [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedar Centre, Royal Surrey County Hospital Guildford Surrey United Kingdom GU2 7XX

    Sponsors and Collaborators

    • University of Surrey
    • Novo Nordisk A/S

    Investigators

    • Principal Investigator: David Russell-Jones, MB BS, University of Surrey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00788840
    Other Study ID Numbers:
    • EC/2008/14/FHMS
    First Posted:
    Nov 11, 2008
    Last Update Posted:
    Nov 11, 2008
    Last Verified:
    Nov 1, 2008
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Isophane Insulin, Human
    Insulin, Isophane
    Isophane insulin, beef

    Study Results

    No Results Posted as of Nov 11, 2008