Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes
1 other identifier
interventional
288
1 country
1
Brief Summary
The purpose of this study is to assess the long term 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 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 P25-P50 for phase_3 diabetes-mellitus-type-2
Started Jun 2005
Shorter than P25 for phase_3 diabetes-mellitus-type-2
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
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 12, 2005
CompletedFirst Posted
Study publicly available on registry
July 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedMay 18, 2017
May 1, 2017
1.1 years
July 12, 2005
May 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c at 24 weeks
Secondary Outcomes (5)
Adverse event profile after 24 weeks of treatment
Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c < 7% after 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:
- Not currently on drug therapy for type 2 diabetes
- Blood glucose criteria must be met
- Body mass index (BMI) in the range 22-45
You may not qualify if:
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Serious cardiovascular events within the past 6 months
- Laboratory value abnormalities as defined by the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
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: 17878242DERIVEDPi-Sunyer FX, Schweizer A, Mills D, Dejager S. Efficacy and tolerability of vildagliptin monotherapy in drug-naive patients with type 2 diabetes. Diabetes Res Clin Pract. 2007 Apr;76(1):132-8. doi: 10.1016/j.diabres.2006.12.009. Epub 2007 Jan 12.
PMID: 17223217DERIVED
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
July 12, 2005
First Posted
July 18, 2005
Study Start
June 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
May 18, 2017
Record last verified: 2017-05