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 - Full Text View

Sponsors and Collaborators:	University Hospital Tuebingen Medical University of Vienna University of Bern CenTrial GmbH
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00656422

Purpose

The main objective of this clinical trial is to investigate weight change as the primary endpoint along with body fat, and hepatic fat 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	Intervention	Phase
Body Weight Changes Obesity	Drug: insulin Levemir Drug: insulin Lantus	Phase III

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Insulin Insulin glargine Insulin Detemir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment
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

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

To describe the weight change from baseline to month 12 between groups. [ Time Frame: at the end ] [ Designated as safety issue: No ]
To evaluate HbA1c between groups. [ Time Frame: at the end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To describe changes in hepatic fat content between groups. [ Time Frame: at the end ] [ Designated as safety issue: Yes ]
To evaluate changes in body fat and visceral adipose tissue between groups. [ Time Frame: at the end ] [ Designated as safety issue: No ]
To describe changes in waist and hip circumferences between groups. [ Time Frame: at the end ] [ Designated as safety issue: No ]
To describe changes in eating behavior and food selection between groups. [ Time Frame: at the end ] [ Designated as safety issue: No ]
To describe changes in well being and disease perception between groups. [ Time Frame: at the end ] [ Designated as safety issue: No ]
To evaluate the daily insulin dose between groups. [ Time Frame: at the end ] [ Designated as safety issue: No ]
To describe the fasting blood glucose between groups. [ Time Frame: at the end ] [ Designated as safety issue: No ]
To evaluate hypoglycaemia between groups. [ Time Frame: at the end ] [ Designated as safety issue: Yes ]
To evaluate safety between groups. [ Time Frame: during the term ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	316
Study Start Date:	November 2007
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
insulin Levemir: Experimental	Drug: insulin Levemir The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.
insulin Lantus: Experimental	Drug: insulin Lantus The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18 years and < 80 years
Gender: female, male
Type 2 diabetes
BMI: 25.0 - 35.0
Anti-GAD antibody negative
Fasting blood glucose > 126 mg/dl
HbA1c 7.0 - 9.0%
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
Therapy with lipid-lowering or anti-hypertensive agent within the last 3 months prior to inclusion into the study
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656422

Contacts

Contact: Andreas Fritsche, Prof. Dr.

49-7071-298-0590

andreas.fritsche@med.uni-tuebingen.de

Locations

Austria
University Hospital Graz	Recruiting
Graz, Austria, 8036
Contact: Hermann Toplak, Prof. Dr.
Sub-Investigator: Antonella de Campo, Dr.
Principal Investigator: Hermann Toplak, Prof. Dr.
Hanusch Hospital	Recruiting
Vienna, Austria, 1140
Contact: Michael Roden, Prof. Dr.
Principal Investigator: Michael Roden, Prof. Dr.
Sub-Investigator: Thomas Wascher, Prof. Dr.
Germany
University Hospital of Tübingen	Recruiting
Tübingen, Germany, 72076
Contact: Andreas Fritsche, Prof. Dr.
Sub-Investigator: Axel Haupt, Dr.
Principal Investigator: Andreas Fritsche, Prof. Dr.
Switzerland
University of Bern Inselspital	Not yet recruiting
Bern, Switzerland, 3010
Contact: Peter Diem, Prof. Dr.
Principal Investigator: Peter Diem, Prof. Dr.

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:	Michael Roden, Prof. Dr.	Hanusch Hospital Vienna
Study Chair:	Thomas Wascher, Prof. Dr.	Hanusch Hospital Vienna
Principal Investigator:	Peter Diem, Prof. Dr.	University of Bern

More Information

Responsible Party:	Medical Department ( University Hospital of Tübingen )
Study ID Numbers:	N-ISP-1, LEV-002
Study First Received:	April 4, 2008
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00656422
Health Authority:	Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices; Austria: Agency for Health and Food Safety; Austria: Ethikkommission; Switzerland: Ethikkommission; Switzerland: Swissmedic

Keywords provided by University Hospital Tuebingen:

insulin therapy
body composition
type 2 diabetes
hepatic fat
comparison of insulin detemir and insulin glargine

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Weight Gain
Insulin
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Glargine
Body Weight Changes
Nutrition Disorders
Overnutrition
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009