To Compare the Efficacy and Safey of Vildagliptin Compared to Voglibose in Patients With Type 2 Diabetes
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
1 other identifier
interventional
370
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 23, 2006
CompletedFirst Posted
Study publicly available on registry
August 24, 2006
CompletedJune 28, 2007
June 1, 2007
August 23, 2006
June 27, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c after 12 weeks
Secondary Outcomes (5)
Change in FPG after 12 weeks
Change in Fasting Lipids after 12 weeks
Change in HOMA-IR after 12 weeks
Change in HOMA-B after 12 weeks
Safety Profile after 12 weeks treatment
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis as Type 2 Diabetes
- Patients who have been placed on dietary therapy/exercise therapy, without achievement of glycemic control
- Outpatients
You may not qualify if:
- Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
- Significant diabetic complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis Pharmaceuticals
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 23, 2006
First Posted
August 24, 2006
Study Start
August 1, 2006
Last Updated
June 28, 2007
Record last verified: 2007-06