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

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Terminated

CT.gov ID

NCT00656422

Collaborator

Medical University of Vienna (Other), University of Bern (Other), CenTrial GmbH (Industry)

Enrollment

Locations

Arms

13.2

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Obesity	Drug: insulin Levemir Drug: insulin Lantus	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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 Start Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: insulin Levemir	Drug: insulin Levemir The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.
Experimental: insulin Lantus	Drug: insulin Lantus The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.

Arm

Intervention/Treatment

Experimental: insulin Levemir

Drug: insulin Levemir

The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.

Experimental: insulin Lantus

Drug: insulin Lantus

The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.

Outcome Measures

Primary Outcome Measures

To describe changes in hepatic fat content between groups. [week 26, week 52]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	University Hospital	Bern	Switzerland	3010

Sponsors and Collaborators

University Hospital Tuebingen
Medical University of Vienna
University of Bern
CenTrial GmbH

Investigators

Principal Investigator: Andreas Fritsche, Prof. Dr., University Hospital of Tübingen
Principal Investigator: Hermann Toplak, Prof. Dr., University Hospital Graz
Study Chair: Peter Diem, Prof. Dr., Bern University Hospital
Study Chair: Alexandra Kautzky-Willer, Prof. Dr., Medical University Vienna
Principal Investigator: Thomas Pieber, Univ. Prof. Dr., Medical University of Graz