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
NCT ID: NCT00656422
Last Updated: 2012-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
66 participants
INTERVENTIONAL
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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insulin Levemir
insulin Levemir
The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.
insulin Lantus
insulin Lantus
The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.
Interventions
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insulin Levemir
The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.
insulin Lantus
The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
University of Bern
OTHER
CenTrial GmbH
INDUSTRY
University Hospital Tuebingen
OTHER
Responsible Party
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Medical Department
Principal Investigators
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Andreas Fritsche, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Tübingen
Hermann Toplak, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Graz
Peter Diem, Prof. Dr.
Role: STUDY_CHAIR
Bern University Hospital
Alexandra Kautzky-Willer, Prof. Dr.
Role: STUDY_CHAIR
Medical University Vienna
Thomas Pieber, Univ. Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
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Medical University Graz
Graz, , Austria
University Hospital Graz
Graz, , Austria
Medical University Vienna
Vienna, , Austria
University Hospital of Tübingen
Tübingen, , Germany
University Hospital
Bern, , Switzerland
Countries
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Other Identifiers
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LEV-002
Identifier Type: -
Identifier Source: secondary_id
N-ISP-1
Identifier Type: -
Identifier Source: org_study_id