Additional identifiers
EudraCT number
2007-003085-17
ClinicalTrials.gov number
NCT00788840
Protocol/serial number
7771
Study information
Scientific title
Acronym
DRN 274 (DEES)
Study hypothesis
This is a 24-week, national, single-centre, open-labelled, randomised, parallel-group trial comparing energy expenditure with insulin detemir versus a neutral protamine hagedorn (NPH) insulin using a basal-bolus regimen with insulin aspart as the mealtime insulin in subjects with type 2 diabetes.
Ethics approval
MREC approved (ref: 07/H1102/108)
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Insulin switch, Metabolic
Intervention
Insulin detemir versus NPH insulin using a basal-bolus regimen with insulin aspart as the mealtime insulin in subjects with type 2 diabetes.
Intervention type
Drug
Phase
Not Applicable
Drug names
Detemir, Insulatard®
Primary outcome measures
Resting and activity energy expenditure
Secondary outcome measures
1. Diet-induced thermogenesis
2. Meal tolerance test analysis of arexigenic and anorexigenic gut hormones
3. Magnetic resonance imaging (MRI) fat distribution
Overall trial start date
01/10/2007
Overall trial end date
01/10/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Type 2 diabetes
2. Treated with metformin
3. Already on treatment with a long-acting or intermediate insulin
4. Aged greater than or equal to 18 years of age, either sex
5. HbA1c greater than 7.0%
6. Body mass index (BMI) 27 - 40 kg/m^2
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 30; UK sample size: 30
Participant 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
Recruitment start date
01/10/2007
Recruitment end date
01/10/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
CEDAR Centre
Guildford
GU2 7XX
United Kingdom
Sponsor information
Organisation
University of Surrey (UK)
Sponsor details
Division of Nutrition
Faculty of Health and Medical Sciences
Guildford
GU2 7XH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Learning about Insulin Bursary for Research and Awareness (LIBRA) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary