A Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes

Phase 3

Completed

• Conditions: Pre-diabetes

• Registration Number: NCT00312130
• Lead Sponsor: Novartis

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 Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2006-04-06
• Study First Submitted QC: 2006-04-06
• Study First Posted: 2006-04-07
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline in acute insulin response to an iv glucose load at 6 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States