Back to resultsExtension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
International
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
Eligibility Criteria
Inclusion Criteria: Only patients successfully completing study CLAF237A2309 are eligible Written informed consent Ability to comply with all study requirements Exclusion Criteria: Premature discontinuation from CLAF237A2309 Other protocol-defined exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative site
Outcomes
Primary Outcome Measures
Safety during 104 weeks of treatment
Change from baseline in HbA1c at 104 weeks
Secondary Outcome Measures
Change in HbA1c between 52 weeks and 104 weeks
Change in fasting plasma glucose between 52 weeks and 104 weeks
Change from baseline in fasting plasma glucose at 104 weeks
Change from baseline in HOMA B at 104 weeks
Change in HOMA B between 52 weeks and 104 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00138567
Brief Title
Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
Official Title
Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This is a 52-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
530 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Primary Outcome Measure Information:
Title
Safety during 104 weeks of treatment
Title
Change from baseline in HbA1c at 104 weeks
Secondary Outcome Measure Information:
Title
Change in HbA1c between 52 weeks and 104 weeks
Title
Change in fasting plasma glucose between 52 weeks and 104 weeks
Title
Change from baseline in fasting plasma glucose at 104 weeks
Title
Change from baseline in HOMA B at 104 weeks
Title
Change in HOMA B between 52 weeks and 104 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Eligibility Criteria
Inclusion Criteria:
Only patients successfully completing study CLAF237A2309 are eligible
Written informed consent
Ability to comply with all study requirements
Exclusion Criteria:
Premature discontinuation from CLAF237A2309
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 Investigative Site
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Facility Name
Novartis Investigative site
City
Investigative Centers
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
18726829
Citation
Goke B, Hershon K, Kerr D, Calle Pascual A, Schweizer A, Foley J, Shao Q, Dejager S. Efficacy and safety of vildagliptin monotherapy during 2-year treatment of drug-naive patients with type 2 diabetes: comparison with metformin. Horm Metab Res. 2008 Dec;40(12):892-5. doi: 10.1055/s-0028-1082334. Epub 2008 Aug 22.
Results Reference
result
PubMed Identifier
32501595
Citation
Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
Results Reference
derived
Learn more about this trial
Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
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