Skip to main content
OpenTrials
Completed

NCT Number: NCT00389415

Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes

This 52-week multicenter open-labeled extension study is designed to assess the long-term safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is open to patients who have completed core study CLAF237A1303.

Completed

Looking for future studies?

Notify Me

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 as Type 2 Diabetes
  • Patients who have completed study CLAF237A1303
  • Outpatients

Exclusion criteria

  • Patients who prematurely discontinued Study CLAF237A1303
  • Other protocol-defined inclusion/exclusioncriterial 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 (100 mg qd) In Patients With Type 2 Diabetes (Extension Study of Study CLAF237A1303)

Important dates

Study start
2006
First posted
Oct 18, 2006
Registry last updated
Nov 27, 2008

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.