Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

Prediabetic State Clinical Trial

Official title:

Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237250
• Other study ID #: CLAF237A2357
• Status: Completed
• Phase: Phase 3
• First received: October 9, 2005
• Last updated: May 4, 2012
• Start date: October 2005
• Est. completion date: July 2006

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetic State

Intervention

Drug:
• vildagliptin

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in area under the 0-2 hour prandial glucose curve at 12 weeks
Secondary	Adverse event profile after 12 weeks of treatment
Secondary	Change in ratio for postprandial insulin AUC and postprandial glucose AUC (0-2 hours) after 12 weeks of treatment
Secondary	Change in HOMA B at 12 weeks
Secondary	Change in fasting insulin at 12 weeks
Secondary	Change in fasting proinsulin/insulin ratio at 12 weeks