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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Collaborators: CenTrial GmbH; Medical University of Vienna; University of Bern
• Treatments: Insulin; Insulin Detemir; Insulin Glargine; Insulin, Globin Zinc

Criteria

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