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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00325429
First Posted: May 12, 2006
Last Update Posted: January 7, 2009
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
  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
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: May 10, 2006
First Posted: May 12, 2006
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