Clinical trial NCT00656422: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes
Obesity
Keywords: insulin therapy
hepatic fat
type 2 diabetes
body composition
comparison of insulin detemir and insulin glargine
Changes in Hepatic Fat
Obesity
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
name: University of Bern
name: CenTrial GmbH
First posted: 2008-04-11
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: To describe changes in hepatic fat content between groups.
timeFrame: week 26, week 52
Secondary outcomes:
measure: 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.
timeFrame: week 26, week 52
measure: To evaluate changes in body fat and visceral adipose tissue between groups.
timeFrame: week 26, week 52
measure: To describe changes in waist and hip circumferences between groups.
timeFrame: weel 26, week 52
measure: To describe changes in eating behavior and food selection between groups.
timeFrame: week 26, week 52
measure: To describe changes in well being and disease perception between groups.
timeFrame: week 26, week 52
measure: To evaluate the daily insulin dose between groups.
timeFrame: 1 year
measure: To describe the fasting blood glucose between groups.
timeFrame: 1 year
measure: To evaluate hypoglycaemia between groups.
timeFrame: 1 year
measure: To evaluate safety between groups.
timeFrame: 1 year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Graz
country: Austria
facility: University Hospital Graz
city: Vienna
country: Austria
facility: Medical University Vienna
city: Tübingen
country: Germany
facility: University Hospital of Tübingen
city: Bern
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital of Tübingen
name: Andreas Fritsche, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Graz
name: Hermann Toplak, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bern University Hospital
name: Peter Diem, Prof. Dr.
role: STUDY_CHAIR
affiliation: Medical University Vienna
name: Alexandra Kautzky-Willer, Prof. Dr.
role: STUDY_CHAIR
affiliation: Medical University of Graz
name: Thomas Pieber, Univ. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: