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
EudraCT/CTIS number	2007-003085-17
ClinicalTrials.gov number	NCT00788840
Secondary identifying numbers	7771

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

CEDAR Centre
Egerton Road
Guildford
GU2 7XX
United Kingdom

Email	no@email.provided

Study information

Study design	Single centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Detemir, Insulatard®
Primary outcome measure	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 study start date	01/10/2007
Completion date	01/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 30; UK sample size: 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

England
United Kingdom

Study participating centre

CEDAR Centre

Guildford
GU2 7XX
United Kingdom

Sponsor information

University of Surrey (UK)
University/education

Division of Nutrition
Faculty of Health and Medical Sciences
Guildford
GU2 7XH
England
United Kingdom

Website	http://www2.surrey.ac.uk/
"ROR"	https://ror.org/00ks66431

Funders

Funder type

Charity

Learning about Insulin Bursary for Research and Awareness (LIBRA) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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