Back to resultsA Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 2
Locations
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 of type 2 diabetes Patients who have been placed on diet and exercise therapy without achievement of glycemic control Outpatients Exclusion Criteria: Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes Significant cardiovascular diseases Significant diabetic complications Other protocol-defined exclusion criteria may apply
Sites / Locations
Outcomes
Primary Outcome Measures
Change from baseline in HbA1c at 12 weeks
Secondary Outcome Measures
Change from baseline for postprandial glucose at 12 weeks
Change from baseline on fasting plasma glucose at 12 weeks
Change from baseline on postprandial glucose AUC at 12 weeks
Change from baseline in HOMA B at 12 weeks
Change from baseline in HOMA IR at 12 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00238498
Brief Title
A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes
Official Title
A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people with type 2 diabetes.
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 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
291 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c at 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline for postprandial glucose at 12 weeks
Title
Change from baseline on fasting plasma glucose at 12 weeks
Title
Change from baseline on postprandial glucose AUC at 12 weeks
Title
Change from baseline in HOMA B at 12 weeks
Title
Change from baseline in HOMA IR at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
Inclusion Criteria:
Diagnosis of type 2 diabetes
Patients who have been placed on diet and exercise therapy without achievement of glycemic control
Outpatients
Exclusion Criteria:
Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
Significant cardiovascular diseases
Significant diabetic complications
Other protocol-defined exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes
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