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
  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:


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 Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 17, 2014