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

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.
 
ClinicalTrials.gov Identifier: NCT00389415
Recruitment Status : Completed
First Posted : October 18, 2006
Last Update Posted : November 27, 2008
Sponsor:
Information provided by:
Novartis

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Vildagliptin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : October 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Adverse events profile after 52 weeks of treatment

Secondary Outcome Measures :
  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

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389415


Locations
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Japan
Novartis Pharmaceuticals
Tokyo, Japan
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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ClinicalTrials.gov Identifier: NCT00389415    
Other Study ID Numbers: CLAF237A1303E1
First Posted: October 18, 2006    Key Record Dates
Last Update Posted: November 27, 2008
Last Verified: November 2008
Keywords provided by Novartis:
Type 2 Diabetes
Vildagliptin
HbA1c
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
 Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action