Back to resultsVildagliptin Compared to Glimepiride 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
glimepiride
Metformin
Vildagliptin matching placebo
Glimepiride matching placebo
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 Body mass index (BMI) in the range 22-45 Blood glucose criteria must be met 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
- Novartis Pharmaceuticals
- Investigative Centers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vildagliptin
Glimepiride
Arm Description
Outcomes
Primary Outcome Measures
Time to HbA1c >8%
Secondary Outcome Measures
Change from baseline in HbA1c at 5 years
Adverse event profile after 5 years of treatment
Coefficient of failure for HbA1c from week 24 to 5 years
Change from baseline in fasting plasma glucose at 5 years
Change from baseline in body weight at 5 years
Full Information
NCT ID
NCT00106340
First Posted
March 22, 2005
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00106340
Brief Title
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
Official Title
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 20, 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
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 long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride 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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vildagliptin
Arm Type
Experimental
Arm Title
Glimepiride
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Other Intervention Name(s)
LAF237, Galvus
Intervention Type
Drug
Intervention Name(s)
glimepiride
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Drug
Intervention Name(s)
Vildagliptin matching placebo
Intervention Type
Drug
Intervention Name(s)
Glimepiride matching placebo
Primary Outcome Measure Information:
Title
Time to HbA1c >8%
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Change from baseline in HbA1c at 5 years
Time Frame
2 years (amended)
Title
Adverse event profile after 5 years of treatment
Time Frame
2 years (amended)
Title
Coefficient of failure for HbA1c from week 24 to 5 years
Time Frame
2 years (amended)
Title
Change from baseline in fasting plasma glucose at 5 years
Time Frame
2 years (amended)
Title
Change from baseline in body weight at 5 years
Time Frame
2 years (amended)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
On a stable dose of metformin as defined by the protocol
Body mass index (BMI) in the range 22-45
Blood glucose criteria must be met
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
Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Facility Name
Investigative Centers
City
Nurnberg
Country
Germany
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2649
Description
Results for CLAF237A2308 from the Novartis Clinical Trials website
Learn more about this trial
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
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