Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00237250

Enrollment

171

Registered

2005-10-12

Start date

2005-10-31

Completion date

2006-07-31

Last updated

2012-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetic State

Keywords

Pre-diabetes, vildagliptin, IGT

Brief summary

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.

Interventions

DRUGvildagliptin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Change in area under the 0-2 hour prandial glucose curve at 12 weeks	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026