Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

Novartis

Status and phase: Completed; Phase 3

Conditions: Prediabetic State

Treatments: Drug: vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00237250

CLAF237A2357

Details and patient eligibility

About

The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people with pre-diabetes who have high blood sugar levels after meals.

Enrollment: 171 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Blood glucose criteria must be met
• Body mass index (BMI) in the range 23-45

Exclusion criteria

• Diagnosis of diabetes
• Serious cardiovascular events within the past 6 months
• Use of insulin or any oral antidiabetic agent
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind