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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00389415
First Posted: October 18, 2006
Last Update Posted: November 27, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
October 16, 2006
October 18, 2006
November 27, 2008
October 2006
Not Provided
Adverse events profile after 52 weeks of treatment
Same as current
Complete list of historical versions of study NCT00389415 on ClinicalTrials.gov Archive Site
  • Change from baseline to endpoint on HbA1c at 52 weeks
  • Change from baseline to endpoint on fasting plasma glucose at 52 weeks
  • Change from baseline to endpoint in HOMA B at 52 weeks
  • Change from baseline to endpoint in HOMA IR at 52 weeks
  • Change from baseline to endpoint in body weight at 52 weeks
Same as current
Not Provided
Not Provided
 
Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Vildagliptin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Not Provided
Not Provided

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00389415
CLAF237A1303E1
Not Provided
Not Provided
Not Provided
Not Provided
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP