- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00389415
Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes
November 26, 2008 updated by: Novartis
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)
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.
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 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
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
October 1, 2006
Study Registration Dates
First Submitted
October 16, 2006
First Submitted That Met QC Criteria
October 16, 2006
First Posted (Estimate)
October 18, 2006
Study Record Updates
Last Update Posted (Estimate)
November 27, 2008
Last Update Submitted That Met QC Criteria
November 26, 2008
Last Verified
November 1, 2008
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
- CLAF237A1303E1
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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