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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

NCT00656422 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2012-11-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

insulin Levemir

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

DRUG

insulin Lantus

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

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • University of Bern

    collaborator OTHER

  • CenTrial GmbH

    collaborator INDUSTRY

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Andreas Fritsche, Prof. Dr. · University Hospital of Tübingen

  • Hermann Toplak, Prof. Dr. · University Hospital Graz

  • Peter Diem, Prof. Dr. · Bern University Hospital

  • Alexandra Kautzky-Willer, Prof. Dr. · Medical University Vienna

  • Thomas Pieber, Univ. Prof. Dr. · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00656422 on ClinicalTrials.gov