A Study To Compare the Effect of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes

Novartis236 enrolled

Overview

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg bid or 100mg qd compared to placebo in patients with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

236

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of type 2 diabetes * Patients who have been placed on dietary therapy/exercise therapy without achievement of glycemic control * Outpatients Exclusion Criteria: * Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes * Significant cardiovascular disease * Significant diabetic complications Other protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Novartis Pharmaceuticals

Tokyo, Japan

Outcomes

Primary Outcomes

Change from baseline on HbA1c at 12 weeks

Secondary Outcomes

Change from baseline on fasting plasma glucose at 12 weeks

Change from baseline on HOMA B at 12 weeks

Change from baseline on HOMA IR at 12 weeks

Change from baseline in body weight at 12 weeks

Change from baseline on fasting lipids at 12 weeks

Data from ClinicalTrials.gov

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