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

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 Glucose

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00312130

Enrollment

Registered

2006-04-07

Start date

2005-04-30

Completion date

2006-11-30

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-diabetes

Keywords

Vildaglptin, Pre-diabetes

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.

Interventions

DRUGVildagliptin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in acute insulin response to an iv glucose load at 6 weeks	—

Secondary

Measure	Time frame
Change from baseline in acute insulin response to an iv glucose load at 8 weeks	—
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026