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

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ClinicalTrials.gov Identifier: NCT00325429
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : January 7, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 in Patients With Type 2 Diabetes
Study Start Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Information from the National Library of Medicine

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

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

Contacts and Locations

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): NCT00325429


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

ClinicalTrials.gov Identifier: NCT00325429     History of Changes
Other Study ID Numbers: CLAF237A1304
First Posted: May 12, 2006    Key Record Dates
Last Update Posted: January 7, 2009
Last Verified: January 2009

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