To Assess the Efficacy and Safety of Vildagliptin as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy

Novartis200 enrolled

Overview

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is designed as a multicenter, randomized, double-blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of type 2 diabetes and treated with a stable dose of sulfonylurea * Patients on diet and exercise who have not reached 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

Change from baseline to endpoint on HbA1c at 12 weeks

Secondary Outcomes

Change from baseline to endpoint on fasting plasma glucose at 12 weeks

Change from baseline to endpoint in HOMA B at 12 weeks

Change from baseline to endpoint in HOMA IR at 12 weeks

Change from baseline to endpoint on fasting lipids at 12 weeks

Adverse events profile after 12 weeks of treatment

Data from ClinicalTrials.gov

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