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

Pre-diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312130
• Other study ID #: CLAF237A2345
• Status: Completed
• Phase: Phase 3
• First received: April 6, 2006
• Last updated: November 16, 2016
• Start date: April 2005
• Est. completion date: November 2006

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Drug:
• Vildagliptin

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

References & Publications (1)

Utzschneider KM, Tong J, Montgomery B, Udayasankar J, Gerchman F, Marcovina SM, Watson CE, Ligueros-Saylan MA, Foley JE, Holst JJ, Deacon CF, Kahn SE. The dipeptidyl peptidase-4 inhibitor vildagliptin improves beta-cell function and insulin sensitivity in — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in acute insulin response to an iv glucose load at 6 weeks
Secondary	Change from baseline in glucose disappearance rate at 6 weeks
Secondary	Change from baseline in glucose disappearance rate at 8 weeks
Secondary	Change from baseline in insulin sensitivity at 6 weeks
Secondary	Change from baseline in insulin sensitivity at 8 weeks
Secondary	Change from baseline in acute insulin response to an iv glucose load at 8 weeks

External Links

•   Results for CLAF237A2345 from the Novartis Clinical Trials website