Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-08-31

Brief Summary

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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 (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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insulin detemir

Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

Insulin detemir once daily plus insulin aspart at mealtime

insulin NPH

Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks

Group Type ACTIVE_COMPARATOR

insulin NPH

Intervention Type DRUG

Insulin NPH once daily plus insulin aspart at mealtime

Interventions

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insulin detemir

Insulin detemir once daily plus insulin aspart at mealtime

Intervention Type DRUG

insulin NPH

Insulin NPH once daily plus insulin aspart at mealtime

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion in trial
* Glycosylated haemoglobin (HbA1c) between 7.0-11.0 %
* Body Mass Index (BMI) between 27.5-40 kg/m\^2

Exclusion Criteria

* Treatment with any oral antidiabetic drugs (OADs) 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, Non-steroidal anti-inflammatory drugs (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 New York Heart Association (NYHA) class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No