A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes
1 other identifier
interventional
59
1 country
1
Brief Summary
This study is not being conducted in the United States. The purpose of this study is to assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function 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 below P25 for phase_3 diabetes-mellitus-type-2
Started Nov 2005
Longer than P75 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
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 29, 2005
CompletedFirst Posted
Study publicly available on registry
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedDecember 17, 2020
January 1, 2013
3.1 years
November 29, 2005
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in hyperglycemia and arginine-stimulated first phase insulin secretion at 52 weeks
52 weeks
Secondary Outcomes (5)
Change from baseline in disposition index at 52 weeks
52 weeks
Change from baseline in hyperglycemia and arginine stimulated second phase insulin secretion at 52 weeks
52 weeks
Change in hyperglycemia-stimulated first phase insulin secretion at 52 weeks
52 weeks
Change in hyperglycemia-stimulated second phase insulin secretion at 52 weeks
52 weeks
Beta-cell function parameter derived from standard meal challenge
52 weeks
Study Arms (2)
vildagliptin
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Not currently on drug therapy for type 2 diabetes
- Blood glucose criteria must be met
You may not qualify if:
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Serious cardiovascular events within the past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Pharmaceuticals
Basel, Switzerland
Related Publications (1)
Foley JE, Bunck MC, Moller-Goede DL, Poelma M, Nijpels G, Eekhoff EM, Schweizer A, Heine RJ, Diamant M. Beta cell function following 1 year vildagliptin or placebo treatment and after 12 week washout in drug-naive patients with type 2 diabetes and mild hyperglycaemia: a randomised controlled trial. Diabetologia. 2011 Aug;54(8):1985-91. doi: 10.1007/s00125-011-2167-8. Epub 2011 May 6.
PMID: 21547496DERIVED
Related Links
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
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2005
First Posted
December 1, 2005
Study Start
November 1, 2005
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
December 17, 2020
Record last verified: 2013-01