A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes

Novartis291 enrolled

Overview

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

291

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of type 2 diabetes * Patients who have been placed on diet and 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 diseases * Significant diabetic complications * Other protocol-defined exclusion criteria may apply

Outcomes

Primary Outcomes

Change from baseline in HbA1c at 12 weeks

Secondary Outcomes

Change from baseline for postprandial glucose at 12 weeks

Change from baseline on fasting plasma glucose at 12 weeks

Change from baseline on postprandial glucose AUC at 12 weeks

Change from baseline in HOMA B at 12 weeks

Change from baseline in HOMA IR at 12 weeks

Data from ClinicalTrials.gov

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