Status:
TERMINATED
Weight Gain, Eating Patterns, and Development of Body Composition During Initiation of Basal Insulin Therapy in Patients With Type 2 Diabetes: A Comparison of Insulin Detemir and Insulin Glargine
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Medical University of Vienna
University of Bern
Conditions:
Diabetes
Obesity
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The main objective of this clinical trial is to investigate hepatic fat as the primary endpoint along with body fat, and weight changes after initiation of a basal insulin therapy together with data a...
Eligibility Criteria
Inclusion
- Age \> 18 years and \< 80 years
- Gender: female, male
- Type 2 diabetes
- BMI: 20.0 - 38.0
- Anti-GAD antibody negative
- Fasting blood glucose \> 126 mg/dl
- HbA1c 7.0 - 11.0%
- Need for insulin therapy
Exclusion
- Previous therapy with insulin within the last 3 months prior to inclusion into the study
- Previous therapy with glitazones within the last 6 months prior to inclusion into the study
- Change in therapy with lipid-lowering or anti-hypertensive agent within one month prior to inclusion into the study (a stable lipid-lowering or anti-hypertensive therapy is allowed)
- Concomitant participation in other clinical trials
- Type 1 diabetes
- Cardiac and macrovascular disease
- Malignancy including leukaemia and lymphoma within the last 5 years
- Liver disease: cirrhosis or chronic active hepatitis, except fat liver
- Significant renal dysfunction
- other Endocrine disease
- significant laboratory abnormalities
- History of active substance abuse (including an average alcohol consume of \> 40g/day and drugs) within the past 2 years
- Female patients: Pregnancy or childbearing potential without adequate contraception (for male patients contraception is not considered as medically important)
- Present therapy with systemic steroids
- Presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI´s
- Use of anti-obesity drugs 3 months prior or during the trial
- Potentially unreliable subjects, probably non compliant subjects, and those judged by the investigator to be unsuitable for the study
- Contraindications for MRI scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia
- Known hypersensitivity to insulin detemir, insulin glargine or to any of the other components
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00656422
Start Date
November 1 2007
Last Update
November 1 2012
Active Locations (5)
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1
Medical University Graz
Graz, Austria, 8036
2
University Hospital Graz
Graz, Austria, 8036
3
Medical University Vienna
Vienna, Austria, 1090
4
University Hospital of Tübingen
Tübingen, Germany, 72076