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
- Registration Number
- NCT00656422
- Lead Sponsor
- University Hospital Tuebingen
- 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 acquisition that is today's standard in studies investigating obesity and eating patterns with insulin detemir and insulin glargine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description insulin Levemir insulin Levemir - insulin Lantus insulin Lantus -
- Primary Outcome Measures
Name Time Method To describe changes in hepatic fat content between groups. week 26, week 52
- Secondary Outcome Measures
Name Time Method To describe the weight changes from baseline to month 12 between the groups following a subcutaneous treatment strategy with either insulin detemir or insulin glargine. week 26, week 52 To evaluate changes in body fat and visceral adipose tissue between groups. week 26, week 52 To describe changes in waist and hip circumferences between groups. weel 26, week 52 To describe changes in eating behavior and food selection between groups. week 26, week 52 To describe changes in well being and disease perception between groups. week 26, week 52 To evaluate the daily insulin dose between groups. 1 year To describe the fasting blood glucose between groups. 1 year To evaluate hypoglycaemia between groups. 1 year To evaluate safety between groups. 1 year
Trial Locations
- Locations (5)
University Hospital of Tübingen
🇩🇪Tübingen, Germany
University Hospital
🇨🇭Bern, Switzerland
Medical University Graz
🇦🇹Graz, Austria
University Hospital Graz
🇦🇹Graz, Austria
Medical University Vienna
🇦🇹Vienna, Austria