The effect of insulin detemir on energy balance, postprandial nutrient handling, body fat distribution and adipose tissue metabolism and gene expression in patients with type 2 diabetes
| ISRCTN | ISRCTN72730583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72730583 |
| ClinicalTrials.gov (NCT) | NCT00788840 |
| Clinical Trials Information System (CTIS) | 2007-003085-17 |
| Protocol serial number | 7771 |
| Sponsor | University of Surrey (UK) |
| Funder | Learning about Insulin Bursary for Research and Awareness (LIBRA) (UK) |
- Submission date
- 30/07/2010
- Registration date
- 30/07/2010
- Last edited
- 21/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Benjamin Sheldon
Scientific
Scientific
CEDAR Centre
Egerton Road
Guildford
GU2 7XX
United Kingdom
| no@email.provided |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effect of insulin detemir on energy balance, postprandial nutrient handling, body fat distribution and adipose tissue metabolism and gene expression in patients with type 2 diabetes |
| Study acronym | DRN 274 (DEES) |
| Study objectives | 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(s) | MREC approved (ref: 07/H1102/108) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Detemir, Insulatard® |
| Primary outcome measure(s) |
Resting and activity energy expenditure |
| Key secondary outcome measure(s) |
1. Diet-induced thermogenesis |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 22 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 01/10/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CEDAR Centre
Guildford
GU2 7XX
United Kingdom
GU2 7XX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 21/04/2020 | No | No |
Editorial Notes
21/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
26/02/2019: No publications found, verifying study status with principal investigator
