Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%
1 other identifier
interventional
251
1 country
1
Brief Summary
This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.
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 Mar 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 12, 2005
CompletedFirst Posted
Study publicly available on registry
January 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedMay 7, 2012
May 1, 2012
1.3 years
January 12, 2005
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c at 12 weeks
Secondary Outcomes (5)
Adverse event profile after 12 weeks of treatment
Patients with reduction in HbA1c >/= 0.7% after 12 weeks
Change from baseline in fasting plasma glucose at 12 weeks
Change from baseline in HOMA-B at 12 weeks
Change from baseline in body weight at 12 weeks
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 (1)
Novartis Pharmaceuticals
Basel, Switzerland
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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2005
First Posted
January 13, 2005
Study Start
March 1, 2004
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
May 7, 2012
Record last verified: 2012-05