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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014