Detemir Energy Expenditure Study (DEES)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Surrey.
Recruitment status was  Recruiting
Novo Nordisk A/S
Information provided by:
University of Surrey Identifier:
First received: November 10, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: Insulatard
Drug: Detemir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • Weight change [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Energy Expenditure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fat composition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fat & muscle gene expression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Glycaemic control [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2008
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00788840

Contact: Benjamin Sheldon, MB BS 01483571122 ext 2405

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

No publications provided

Responsible Party: Professor David Russell-Jones, Cedar Centre, Royal Surrey County Hospital, Guildford, UK GU2 7XX Identifier: NCT00788840     History of Changes
Other Study ID Numbers: EC/2008/14/FHMS
Study First Received: November 10, 2008
Last Updated: November 10, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Isophane
Isophane insulin, beef
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 25, 2015