Long-Term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

Novartis150 enrolled

Overview

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 52-week clinical study is designed as an open label, long-term study aimed to evaluate the safety of vildagliptin in patients with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

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 diet and exercise therapy without achieving target blood glucose levels * Outpatients Exclusion Criteria: * Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes * Significant cardiovascular complications as defined by the protocol * Significant diabetic complications as defined by the protocol Other protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Novartis Pharmaceuticals

Tokyo, Japan

Outcomes

Primary Outcomes

Adverse events profile after 52 weeks of treatment

Secondary Outcomes

Change from baseline to endpoint on HbA1c at 52 weeks

Change from baseline to endpoint on fasting plasma glucose at 52 weeks

Change from baseline to endpoint in HOMA B at 52 weeks

Change from baseline to endpoint in HOMA IR at 52 weeks

Change from baseline to endpoint in body weight at 52 weeks

Data from ClinicalTrials.gov

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