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

Novartis370 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

370

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Pharmaceuticals

Tokyo, Japan

Outcomes

Primary Outcomes

Change in HbA1c after 12 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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