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Detemir Energy Expenditure Study (DEES)

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ClinicalTrials.gov Identifier: NCT00788840
Recruitment Status : Unknown
Verified November 2008 by University of Surrey.
Recruitment status was:  Recruiting
First Posted : November 11, 2008
Last Update Posted : November 11, 2008
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Obesity Drug: Insulatard Drug: Detemir Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2008
Estimated Primary Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Levemir



Primary Outcome Measures :
  1. Weight change [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Energy Expenditure [ Time Frame: 6 months ]
  2. Fat composition [ Time Frame: 6 months ]
  3. Fat & muscle gene expression [ Time Frame: 6 months ]
  4. Glycaemic control [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788840


Contacts
Contact: Benjamin Sheldon, MB BS 01483571122 ext 2405 benjamin.sheldon@nhs.net

Locations
United Kingdom
Cedar Centre, Royal Surrey County Hospital Recruiting
Guildford, Surrey, United Kingdom, GU2 7XX
Contact: Benjamin Sheldon, MB BS    01483571122 ext 2405    benjamin.sheldon@nhs.net   
Sub-Investigator: Benjamin Sheldon, MB BS         
Sponsors and Collaborators
University of Surrey
Novo Nordisk A/S
Investigators
Principal Investigator: David Russell-Jones, MB BS University of Surrey

Responsible Party: Professor David Russell-Jones, Cedar Centre, Royal Surrey County Hospital, Guildford, UK GU2 7XX
ClinicalTrials.gov Identifier: NCT00788840     History of Changes
Other Study ID Numbers: EC/2008/14/FHMS
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: November 11, 2008
Last Verified: November 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Isophane insulin, beef
Insulin
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs