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OpenTrials
Completed

NCT Number: NCT00238498

A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people with type 2 diabetes.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

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

Inclusion criteria

  • Diagnosis of type 2 diabetes
  • Patients who have been placed on diet and exercise therapy without achievement of glycemic control
  • Outpatients

Exclusion criteria

  • Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant cardiovascular diseases
  • Significant diabetic complications
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. Change from baseline in HbA1c at 12 weeks

Secondary outcomes

  1. Change from baseline for postprandial glucose at 12 weeks

  2. Change from baseline on fasting plasma glucose at 12 weeks

  3. Change from baseline on postprandial glucose AUC at 12 weeks

  4. Change from baseline in HOMA B at 12 weeks

  5. Change from baseline in HOMA IR at 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Oct 13, 2005
Registry last updated
May 2, 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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