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OpenTrials
Completed

NCT Number: NCT00237250

Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 12, 2005
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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