A Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes
A Single-blind, Single-treatment Study to Evaluate the Effects of Vildagliptin on Response to an Intravenous Glucose Load in Pre-diabetic Subjects With Impaired Fasting Glucose
1 other identifier
interventional
20
1 country
1
Brief Summary
This is an exploratory study to assess whether vildagliptin, an unapproved drug, can increase insulin secretion in subjects with pre-diabetes who have a defect in the insulin response and elevated levels of fasting glucose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2005
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, 2005
CompletedFirst Submitted
Initial submission to the registry
April 6, 2006
CompletedFirst Posted
Study publicly available on registry
April 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedNovember 18, 2016
November 1, 2016
1.6 years
April 6, 2006
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in acute insulin response to an iv glucose load at 6 weeks
Secondary Outcomes (5)
Change from baseline in glucose disappearance rate at 6 weeks
Change from baseline in glucose disappearance rate at 8 weeks
Change from baseline in insulin sensitivity at 6 weeks
Change from baseline in insulin sensitivity at 8 weeks
Change from baseline in acute insulin response to an iv glucose load at 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- BMI in the range 22-45 and with a stable weight for the last 6 months
- Blood glucose criteria must be met
- Written informed consent
You may not qualify if:
- Pregnancy or lactation
- Previous diagnosis of type 2 diabetes or treatment with hypoglycemic agents
- Type 1 diabetes
- Evidence of cardiovascular complications as defined by the protocol
- Evidence of diabetic complications as defined by the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
University of Washington
Seattle, Washington, 98108, United States
Related Publications (1)
Utzschneider KM, Tong J, Montgomery B, Udayasankar J, Gerchman F, Marcovina SM, Watson CE, Ligueros-Saylan MA, Foley JE, Holst JJ, Deacon CF, Kahn SE. The dipeptidyl peptidase-4 inhibitor vildagliptin improves beta-cell function and insulin sensitivity in subjects with impaired fasting glucose. Diabetes Care. 2008 Jan;31(1):108-13. doi: 10.2337/dc07-1441. Epub 2007 Oct 1.
PMID: 17909087RESULT
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
- NON RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2006
First Posted
April 7, 2006
Study Start
April 1, 2005
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
November 18, 2016
Record last verified: 2016-11