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

Novartis20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pre-diabetes

Interventions

VildagliptinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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