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

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

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 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

Resource links provided by the National Library of Medicine





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


Information from the National Library of Medicine

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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

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
Japan
Novartis Pharmaceuticals
Tokyo, Japan
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00389415     History of Changes
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs