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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Vildagliptin

Criteria

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

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