Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

Novartis171 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

171

Conditions

Prediabetic State

Interventions

vildagliptinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Change in area under the 0-2 hour prandial glucose curve at 12 weeks

Secondary Outcomes

Adverse event profile after 12 weeks of treatment

Change in ratio for postprandial insulin AUC and postprandial glucose AUC (0-2 hours) after 12 weeks of treatment

Change in HOMA B at 12 weeks

Change in fasting insulin at 12 weeks

Change in fasting proinsulin/insulin ratio at 12 weeks

Data from ClinicalTrials.gov

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