- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00325429
Long-Term Safety Study of Vildagliptin in Patients With Type 2 Diabetes
January 6, 2009 updated by: Novartis
A Multicenter, Open, Long Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes
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.
Study Overview
Study Type
Interventional
Enrollment
150
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan
- Novartis Pharmaceuticals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Adverse events profile after 52 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
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Change from baseline to endpoint on HbA1c at 52 weeks
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Change from baseline to endpoint on fasting plasma glucose at 52 weeks
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Change from baseline to endpoint in HOMA B at 52 weeks
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Change from baseline to endpoint in HOMA IR at 52 weeks
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Change from baseline to endpoint in body weight at 52 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Study Registration Dates
First Submitted
May 10, 2006
First Submitted That Met QC Criteria
May 10, 2006
First Posted (Estimate)
May 12, 2006
Study Record Updates
Last Update Posted (Estimate)
January 7, 2009
Last Update Submitted That Met QC Criteria
January 6, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Vildagliptin
Other Study ID Numbers
- CLAF237A1304
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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