Detemir Energy Expenditure Study - Full Text View

Sponsors and Collaborators:	University of Surrey Novo Nordisk
Information provided by:	University of Surrey
ClinicalTrials.gov Identifier:	NCT00788840

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus Obesity	Drug: Insulatard Drug: Detemir	Phase IV

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Insulin Insulin aspart Insulin Detemir Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by University of Surrey:

Primary Outcome Measures:

Weight change [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Energy Expenditure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Fat composition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Fat & muscle gene expression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Glycaemic control [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Insulatard: Active Comparator	Drug: Insulatard Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.
2. Detemir: Active Comparator	Drug: Detemir Detemir insulin used as long-acting insulin in treatment phase of study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788840

Contacts

Contact: Benjamin Sheldon, MB BS

01483571122 ext 2405

benjamin.sheldon@nhs.net

Locations

United Kingdom, Surrey
Cedar Centre, Royal Surrey County Hospital	Recruiting
Guildford, Surrey, United Kingdom, GU2 7XX
Contact: Benjamin Sheldon, MB BS 01483571122 ext 2405 benjamin.sheldon@nhs.net
Sub-Investigator: Benjamin Sheldon, MB BS

Sponsors and Collaborators

University of Surrey

Novo Nordisk

Investigators

Principal Investigator:

David Russell-Jones, MB BS

University of Surrey

More Information

Responsible Party:	Cedar Centre, Royal Surrey County Hospital, Guildford, UK GU2 7XX ( Professor David Russell-Jones )
Study ID Numbers:	EC/2008/14/FHMS
Study First Received:	November 10, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00788840
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Insulin, Isophane
Insulin
Body Weight
Signs and Symptoms

Insulin, Long-Acting
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

ClinicalTrials.gov processed this record on January 16, 2009