Back to resultsLong Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Vildagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 Diabetes, Vildagliptin, HbA1c
Eligibility Criteria
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
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00389415
Brief Title
Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 Diabetes, Vildagliptin, HbA1c
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Primary Outcome Measure Information:
Title
Adverse events profile after 52 weeks of treatment
Secondary Outcome Measure Information:
Title
Change from baseline to endpoint on HbA1c at 52 weeks
Title
Change from baseline to endpoint on fasting plasma glucose at 52 weeks
Title
Change from baseline to endpoint in HOMA B at 52 weeks
Title
Change from baseline to endpoint in HOMA IR at 52 weeks
Title
Change from baseline to endpoint in body weight at 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes
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