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Detemir Energy Expenditure Study (DEES)

Primary Purpose

Type 2 Diabetes Mellitus, Obesity

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Insulatard
Detemir
Sponsored by
University of Surrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedar Centre, Royal Surrey County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1. Insulatard

2. Detemir

Arm Description

Outcomes

Primary Outcome Measures

Weight change

Secondary Outcome Measures

Energy Expenditure
Fat composition
Fat & muscle gene expression
Glycaemic control

Full Information

First Posted
November 10, 2008
Last Updated
May 26, 2023
Sponsor
University of Surrey
Collaborators
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00788840
Brief Title
Detemir Energy Expenditure Study
Acronym
DEES
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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2008 (Actual)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Surrey
Collaborators
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Insulatard
Arm Type
Active Comparator
Arm Title
2. Detemir
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Insulatard
Intervention Description
Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.
Intervention Type
Drug
Intervention Name(s)
Detemir
Other Intervention Name(s)
Levemir
Intervention Description
Detemir insulin used as long-acting insulin in treatment phase of study.
Primary Outcome Measure Information:
Title
Weight change
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Energy Expenditure
Time Frame
6 months
Title
Fat composition
Time Frame
6 months
Title
Fat & muscle gene expression
Time Frame
6 months
Title
Glycaemic control
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes Treated with metformin Already on treatment with a long-acting or intermediate insulin. Over 18 years of age, HbA1c > 7.0% BMI 27-40 Able and willing to perform self-blood glucose monitoring. Able and willing to maintain consistent eating habits throughout the entire trial period. Able and willing to maintain consistent physical activity level during the entire trial period Exclusion Criteria: Patients on sulphonylureas or thiazolidinediones Proliferative retinopathy that has required acute treatment within the last six months. Impaired hepatic or renal functions. Cardiac problems. Uncontrolled hypertension (treated or untreated). Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Russell-Jones, MB BS
Organizational Affiliation
University of Surrey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedar Centre, Royal Surrey County Hospital
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33166419
Citation
Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
Results Reference
derived

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Detemir Energy Expenditure Study

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