Overview

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/SNRIĀ“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