Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/07/2010
Date assigned
30/07/2010
Last edited
19/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Benjamin Sheldon

ORCID ID

Contact details

CEDAR Centre
Egerton Road
Guildford
GU2 7XX
United Kingdom

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

http://www2.surrey.ac.uk/

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

Publication citations

Additional files

Editorial Notes