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
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
University of Surrey
ClinicalTrials.gov Identifier:
NCT00788840
First received: November 10, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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
Obesity
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Isophane insulin, beef
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014