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

Novartis

Status and phase: Completed; Phase 3

Conditions: Pre-diabetes

Treatments: Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00312130

CLAF237A2345

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind