A Study to Assess the Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00351507

Purpose

This study was designed to directly assess the effects of vildagliptin on gastric emptying in people with type 2 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Vildagliptin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	A Double-Blind, Crossover, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Vildagliptin on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes

Further study details as provided by Novartis:

Primary Outcome Measures:

Secondary Outcome Measures:

Effect on gastric volume
Effect on satiety
Effect on endogenous glucose appearance, glucose appearance and glucose disposal

Estimated Enrollment:	18
Study Start Date:	May 2005

Eligibility

Ages Eligible for Study:	35 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Exclusion Criteria:

History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
Use of thiazolidinediones or need for insulin within 3 months prior to screening
Significant concomitant diseases or complications of diabetes
High fasting triglycerides as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351507

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Adrian Vella, MD

Mayo Clinic & Foundation

More Information

Publications indexed to this study:

Study ID Numbers:	CLAF237A2343
Study First Received:	July 11, 2006
Last Updated:	July 11, 2006
ClinicalTrials.gov Identifier:	NCT00351507
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Vildagliptin
Type 2 diabetes

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Vildagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009