Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
1 other identifier
interventional
530
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started Jan 2005
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 27, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedNovember 18, 2016
November 1, 2016
1.6 years
August 27, 2005
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety during 104 weeks of treatment
Change from baseline in HbA1c at 104 weeks
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- Only patients successfully completing study CLAF237A2309 are eligible
- Written informed consent
- Ability to comply with all study requirements
You may not qualify if:
- Premature discontinuation from CLAF237A2309
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (2)
Novartis Investigative Site
East Hanover, New Jersey, 07936, United States
Novartis Investigative site
Investigative Centers, Germany
Related Publications (2)
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.
PMID: 18726829RESULTGnesin 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.
PMID: 32501595DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2005
First Posted
August 30, 2005
Study Start
January 1, 2005
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
November 18, 2016
Record last verified: 2016-11