Status:
COMPLETED
Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ins...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00795600
Start Date
April 1 2009
End Date
August 1 2010
Last Update
March 16 2016
Active Locations (1)
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1
Málaga, Spain, 29009