Back to resultsVildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
vildagliptin
Gliclazide
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring type 2 diabetes, vildagliptin
Eligibility Criteria
Inclusion Criteria: On a stable dose of metformin as defined by the protocol Blood glucose criteria must be met Body mass index (BMI) in the range 22-45 Exclusion Criteria: Pregnancy or lactation Type 1 diabetes Evidence of significant diabetic complications Evidence of serious cardiovascular complications Laboratory value abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply
Sites / Locations
- Investigative Centers
- Novartis Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vildagliptin
Gliclazide
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in HbA1c at 52 weeks
Secondary Outcome Measures
Adverse event profile after 52 weeks of treatment
Change from baseline in fasting plasma glucose at 52 weeks
Patients with endpoint HbA1c <7% at 52 weeks
Patients with reduction in HbA1c >/= 0.7% after 52 weeks
Patients with reduction in HbA1c >/= 0.5% after 52 weeks
Full Information
NCT ID
NCT00102466
First Posted
January 29, 2005
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00102466
Brief Title
Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
Official Title
Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study is not being conducted in the United States. Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1007 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vildagliptin
Arm Type
Experimental
Arm Title
Gliclazide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Intervention Type
Drug
Intervention Name(s)
Gliclazide
Intervention Type
Drug
Intervention Name(s)
Metformin
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c at 52 weeks
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Adverse event profile after 52 weeks of treatment
Time Frame
52 weeks
Title
Change from baseline in fasting plasma glucose at 52 weeks
Time Frame
52 weeks
Title
Patients with endpoint HbA1c <7% at 52 weeks
Time Frame
52 weeks
Title
Patients with reduction in HbA1c >/= 0.7% after 52 weeks
Time Frame
52 weeks
Title
Patients with reduction in HbA1c >/= 0.5% after 52 weeks
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
On a stable dose of metformin as defined by the protocol
Blood glucose criteria must be met
Body mass index (BMI) in the range 22-45
Exclusion Criteria:
Pregnancy or lactation
Type 1 diabetes
Evidence of significant diabetic complications
Evidence of serious cardiovascular complications
Laboratory value abnormalities as defined by the protocol
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
Facility Information:
Facility Name
Investigative Centers
City
Nurnberg
Country
Germany
Facility Name
Novartis Pharmaceuticals
City
Basel
Country
Switzerland
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2851
Description
Results for CLAF237A2338 from the Novartis Clinical Trials website
Learn more about this trial
Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
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