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NCT00368134 Clinical Trial

To Compare the Efficacy and Safey of Vildagliptin Compared to Voglibose in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00368134
Other study ID # CLAF237A1301
Secondary ID
Status Completed
Phase Phase 3
First received August 23, 2006
Last updated June 27, 2007
Start date August 2006

Study information
Verified date June 2007
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 370
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 20 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin

Locations
Country Name City State
Japan Novartis Pharmaceuticals Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c after 12 weeks
Secondary Change in FPG after 12 weeks
Secondary Change in Fasting Lipids after 12 weeks
Secondary Change in HOMA-IR after 12 weeks
Secondary Change in HOMA-B after 12 weeks
Secondary Safety Profile after 12 weeks treatment
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