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Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

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ClinicalTrials.gov Identifier: NCT00237250
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : May 7, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

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.

Condition or disease Intervention/treatment Phase
Prediabetic State Drug: vildagliptin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
Study Start Date : October 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources




Primary Outcome Measures :
  1. Change in area under the 0-2 hour prandial glucose curve at 12 weeks

Secondary Outcome Measures :
  1. Adverse event profile after 12 weeks of treatment
  2. Change in ratio for postprandial insulin AUC and postprandial glucose AUC (0-2 hours) after 12 weeks of treatment
  3. Change in HOMA B at 12 weeks
  4. Change in fasting insulin at 12 weeks
  5. Change in fasting proinsulin/insulin ratio at 12 weeks


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

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
Hypoglycemic Agents
Physiological Effects of Drugs