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

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Descriptive Information Fields

Brief Title ^†

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

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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 Measure ^†

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 ]

Condition ^†

Diabetes Mellitus, Type 2

Intervention ^†

Drug: insulin detemir
Drug: insulin NPH

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

Start Date ^†

December 2008

Completion Date

December 2009

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Location Countries ^†

Spain

Administrative Information Fields

NCT ID ^†

NCT00795600

Organization ID

NN304-3614

Secondary IDs ^††

EudraCT No: 2008-003739-19

Study Sponsor ^†

Novo Nordisk

Collaborators ^††

Investigators ^†

Study Director:

Fernando Fuentes, PhD

Novo Nordisk Pharma SA

Information Provided By

Novo Nordisk

Verification Date

November 2008

First Received Date ^†

November 20, 2008

Last Updated Date

November 21, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.