Detemir Energy Expenditure Study
DEES
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 type-2-diabetes-mellitus
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 10, 2008
CompletedFirst Posted
Study publicly available on registry
November 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedMay 31, 2023
May 1, 2023
1.6 years
November 10, 2008
May 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Weight change
6 months
Secondary Outcomes (4)
Energy Expenditure
6 months
Fat composition
6 months
Fat & muscle gene expression
6 months
Glycaemic control
6 months
Study Arms (2)
1. Insulatard
ACTIVE COMPARATOR2. Detemir
ACTIVE COMPARATORInterventions
Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.
Detemir insulin used as long-acting insulin in treatment phase of study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Surreylead
- Novo Nordisk A/Scollaborator
Study Sites (1)
Cedar Centre, Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Related Publications (1)
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.
PMID: 33166419DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Russell-Jones, MB BS
University of Surrey
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2008
First Posted
November 11, 2008
Study Start
January 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
May 31, 2023
Record last verified: 2023-05