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

This study has been completed.

First Received: April 6, 2006 Last Updated: November 10, 2006 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00312130

Purpose

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.

Condition	Intervention	Phase
Pre-Diabetes	Drug: Vildagliptin	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose Vildagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment, Pharmacodynamics Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312130

Locations

United States, Washington
University of Washington
Seattle, Washington, United States, 98108

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CLAF237A2345
Study First Received:	April 6, 2006
Last Updated:	November 10, 2006
ClinicalTrials.gov Identifier:	NCT00312130 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Vildaglptin
Pre-diabetes

Study placed in the following topic categories:

Metabolic Diseases
Glucose Intolerance
Diabetes Mellitus
Prediabetic State
Endocrine System Diseases
Vildagliptin
Insulin

Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Hyperglycemia
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Glucose Intolerance
Diabetes Mellitus
Prediabetic State
Endocrine System Diseases
Enzyme Inhibitors

Vildagliptin
Pharmacologic Actions
Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Hyperglycemia
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009