Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes
1 other identifier
interventional
717
2 countries
2
Brief Summary
The purpose of this study is 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started May 2004
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
May 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
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedMay 17, 2017
May 1, 2017
1.3 years
December 21, 2004
May 15, 2017
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
Adverse event profile after 24 weeks of treatment
Patients with endpoint HbA1c <7% at 24 weeks
Patients with reduction in HbA1c >/= 0.7% after 24 weeks
Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c
Interventions
Eligibility Criteria
You may qualify if:
- Blood glucose criteria must be met
- Not currently on drug therapy for type 2 diabetes
- Body mass index (BMI) in the range 22-45
You may not qualify if:
- Pregnancy or lactation
- 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 (2)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Novartis Investigative Sites
Investigative Centers, Germany
Related Publications (3)
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: 17878242DERIVEDRosenstock J, Baron MA, Dejager S, Mills D, Schweizer A. Comparison of vildagliptin and rosiglitazone monotherapy in patients with type 2 diabetes: a 24-week, double-blind, randomized trial. Diabetes Care. 2007 Feb;30(2):217-23. doi: 10.2337/dc06-1815.
PMID: 17259484DERIVED
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
December 21, 2004
First Posted
December 22, 2004
Study Start
May 1, 2004
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
May 17, 2017
Record last verified: 2017-05