Detemir Energy Expenditure Study (DEES)

May 26, 2023 updated by: University of Surrey

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Cedar Centre, Royal Surrey County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight change
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Energy Expenditure
Time Frame: 6 months
6 months
Fat composition
Time Frame: 6 months
6 months
Fat & muscle gene expression
Time Frame: 6 months
6 months
Glycaemic control
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Surrey

Collaborators

Novo Nordisk A/S

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimated)

November 11, 2008

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2008/14/FHMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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