A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes
1 other identifier
interventional
639
1 country
1
Brief Summary
The purpose of this study is to assess the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo 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.
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 Apr 2004
1 active site
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
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 21, 2004
CompletedFirst Posted
Study publicly available on registry
December 22, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedMay 2, 2012
May 1, 2012
1.5 years
December 21, 2004
May 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c at 24 weeks
Secondary Outcomes (5)
Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks
Patients with reduction in HbA1c>/=to 0.7% after 24 weeks
Change from baseline in body weight at 24 weeks
Change from baseline in fasting lipids at 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) in the range 22-45
- Blood glucose criteria must be met
- Not currently on drug therapy for type 2 diabetes
You may not qualify if:
- Type 1 diabetes
- Evidence of serious diabetic complications
- Evidence of serious cardiovascular conditions
- Laboratory value abnormalities as defined by the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Related Publications (2)
Pratley RE, Schweizer A, Rosenstock J, Foley JE, Banerji MA, Pi-Sunyer FX, Mills D, Dejager S. Robust improvements in fasting and prandial measures of beta-cell function with vildagliptin in drug-naive patients: analysis of pooled vildagliptin monotherapy database. Diabetes Obes Metab. 2008 Sep;10(10):931-8. doi: 10.1111/j.1463-1326.2007.00835.x. Epub 2007 Dec 17.
PMID: 18093207DERIVEDPratley RE, Rosenstock J, Pi-Sunyer FX, Banerji MA, Schweizer A, Couturier A, Dejager S. Management of type 2 diabetes in treatment-naive elderly patients: benefits and risks of vildagliptin monotherapy. Diabetes Care. 2007 Dec;30(12):3017-22. doi: 10.2337/dc07-1188. Epub 2007 Sep 18.
PMID: 17878242DERIVED
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
Study Record Dates
First Submitted
December 21, 2004
First Posted
December 22, 2004
Study Start
April 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
May 2, 2012
Record last verified: 2012-05