Clinical Trial: A Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Gl
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.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Change from baseline in acute insulin response to an iv glucose load at 6 weeks
Original Primary Outcome:
Current Secondary Outcome:
- 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
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: April 6, 2006
Date Started: April 2005
Date Completion:
Last Updated: November 16, 2016
Last Verified: November 2016
