Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00237250

First received: October 9, 2005

Last updated: May 4, 2012

Last verified: May 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Prediabetic State	Drug: vildagliptin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Pre-diabetes

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	171
Study Start Date:	October 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237250

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rosenstock J, Foley JE, Rendell M, Landin-Olsson M, Holst JJ, Deacon CF, Rochotte E, Baron MA. Effects of the dipeptidyl peptidase-IV inhibitor vildagliptin on incretin hormones, islet function, and postprandial glycemia in subjects with impaired glucose tolerance. Diabetes Care. 2008 Jan;31(1):30-5. Epub 2007 Oct 18.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00237250 History of Changes
Other Study ID Numbers:	CLAF237A2357
Study First Received:	October 9, 2005
Last Updated:	May 4, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Pre-diabetes
vildagliptin
IGT

Additional relevant MeSH terms:

Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Vildagliptin

Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013

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