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OpenTrials
Completed

NCT Number: NCT00325429

Long-Term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 52-week clinical study is designed as an open label, long-term study aimed to evaluate the safety of vildagliptin in patients 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

Tokyo, Japan

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 achieving target blood glucose levels
  • Outpatients

Exclusion criteria

  • Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant cardiovascular complications as defined by the protocol
  • Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. Adverse events profile after 52 weeks of treatment

Secondary outcomes

  1. Change from baseline to endpoint on HbA1c at 52 weeks

  2. Change from baseline to endpoint on fasting plasma glucose at 52 weeks

  3. Change from baseline to endpoint in HOMA B at 52 weeks

  4. Change from baseline to endpoint in HOMA IR at 52 weeks

  5. Change from baseline to endpoint in body weight at 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multicenter, Open, Long Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes

Important dates

Study start
2006
First posted
May 12, 2006
Registry last updated
Jan 7, 2009

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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