Comparison of the Change in Fat Distribution in Overweight and Obese Type 2 Diabetics After Insulin Treatment - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00795600

Purpose

This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (both combined with insulin aspart in the main meals) in overweight and obese type 2 diabetics.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin detemir Drug: insulin NPH	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, Safety/Efficacy Study
Official Title:	Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes Mellitus After 26 Weeks of Treatment With Insulin Detemir Versus Insulin NPH Both Combined With Insulin Aspart

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

to compare the change in trunk fat mass assessed by DEXA [ Time Frame: at baseline and 26 weeks of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

additional for DEXA: Whole Body Fat Mass (g), Whole Body Lean Mass (g), Trunk Lean Mass (g), Calculated Whole Body Fat Percentage and Calculated Trunk Fat Percentage [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ]
cT scan: Visceral Adipose Tissue Area (cm2), Subcutaneous Adipose Tissue Area (cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio and Liver/Spleen Attenuation Ratio (L/S) [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ]
change in HbA1c [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ]
change in Fasting Plasma Glucose (FPG) [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ]
to quantify the relationship between BMI and required daily dose of insulin detemir [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ]
to quantify the cytokine in the adipose tissue (adiponectin) [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ]
incidence of hypoglycaemia [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: Yes ]
lipid profile [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ]
incidence of Adverse events during the trial [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: Yes ]
safety profile as measured by laboratory safety parameters [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: Yes ]
weight and waist/hip circumference [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ]
to quantify the inflammatory parameters (hsCRP and PAI-1) [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	58
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: insulin detemir Insulin detemir once daily plus insulin aspart at mealtime
B: Active Comparator	Drug: insulin NPH Insulin NPH once daily plus insulin aspart at mealtime

Eligibility

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

Criteria

Inclusion Criteria:

Subjects with type 2 diabetes who have been treated with 2 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion
HbA1c between 7.0 - 11.0 %
BMI between 27.5kg/m2 - 40 kg/m2

Exclusion Criteria:

Treatment with any OAD (Oral Antidiabetic Drugs) in the last 6 months, except metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, NSAIDs, tricyclic anti-depressants, atypical anti-psychotics)
Previous or planned surgical treatment of obesity
Total daily insulin dose higher or equal 2 IU/kg.
Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
Receipt of any investigational drug within 1 month prior to this trial
Cardiac disease defined according to NYHA class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795600

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Locations

Spain

Málaga, Spain, 29009

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Fernando Fuentes, PhD

Novo Nordisk Pharma SA

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-3614, EudraCT No: 2008-003739-19
Study First Received:	November 20, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00795600
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases

Overweight
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009