Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes
1 other identifier
interventional
478
2 countries
2
Brief Summary
This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been 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 Nov 2004
Typical duration for phase_3 diabetes-mellitus-type-2
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
November 1, 2004
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
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedMay 7, 2012
May 1, 2012
2.4 years
August 27, 2005
May 4, 2012
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 24 weeks and 104 weeks
Change from baseline in fasting plasma glucose at 104 weeks
Change in fasting plasma glucose between 24 weeks and 104 weeks
Change from baseline in HOMA B at 104 weeks
Change in HOMA B between 24 weeks and 104 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Only patients successfully completing study CLAF237A2327 are eligible
- Written informed consent
- Ability to comply with all study requirements
You may not qualify if:
- Premature discontinuation from study CLAF237A2327
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (2)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Unknown Facility
Investigative Centers, Germany
Related Publications (1)
Rosenstock J, Niggli M, Maldonado-Lutomirsky M. Long-term 2-year safety and efficacy of vildagliptin compared with rosiglitazone in drug-naive patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 Jun;11(6):571-8. doi: 10.1111/j.1463-1326.2008.01021.x. Epub 2009 Apr 5.
PMID: 19383032DERIVED
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
November 1, 2004
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
May 7, 2012
Record last verified: 2012-05