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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00325429
First received: May 10, 2006
Last updated: January 6, 2009
Last verified: January 2009
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Vildagliptin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Adverse events profile after 52 weeks of treatment

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 150
Study Start Date: April 2006
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325429

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

No publications provided

ClinicalTrials.gov Identifier: NCT00325429     History of Changes
Other Study ID Numbers: CLAF237A1304
Study First Received: May 10, 2006
Last Updated: January 6, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013