- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00368134
To Compare the Efficacy and Safey of Vildagliptin Compared to Voglibose in Patients With Type 2 Diabetes
June 27, 2007 updated by: Novartis
A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Compare the Effects of 12 Weeks Treatment With Vildagliptin 50 mg Bid to Voglibose 0.2 mg Tid in Patients With Type 2 Diabetes
This study is designed to evaluate the efficacy, safety and tolerability of vildagliptin compared to voglibose in patients with type 2 diabetes.
Please note this study is not being conducted in the United States.
Study Overview
Study Type
Interventional
Enrollment
370
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan
- Novartis Pharmaceuticals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis as Type 2 Diabetes
- Patients who have been placed on dietary therapy/exercise therapy, without achievement of glycemic control
- Outpatients
Exclusion Criteria:
- Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
- Significant diabetic complications
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change in HbA1c after 12 weeks
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Secondary Outcome Measures
Outcome Measure |
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Change in FPG after 12 weeks
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Change in Fasting Lipids after 12 weeks
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Change in HOMA-IR after 12 weeks
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Change in HOMA-B after 12 weeks
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Safety Profile after 12 weeks treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Study Registration Dates
First Submitted
August 23, 2006
First Submitted That Met QC Criteria
August 23, 2006
First Posted (Estimate)
August 24, 2006
Study Record Updates
Last Update Posted (Estimate)
June 28, 2007
Last Update Submitted That Met QC Criteria
June 27, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Vildagliptin
Other Study ID Numbers
- CLAF237A1301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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