A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00238498

Purpose

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people with type 2 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: vildagliptin	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Vildagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in HbA1c at 12 weeks

Secondary Outcome Measures:

Change from baseline for postprandial glucose at 12 weeks
Change from baseline on fasting plasma glucose at 12 weeks
Change from baseline on postprandial glucose AUC at 12 weeks
Change from baseline in HOMA B at 12 weeks
Change from baseline in HOMA IR at 12 weeks

Estimated Enrollment:	344
Study Start Date:	July 2004

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Diagnosis of type 2 diabetes
Patients who have been placed on diet and exercise therapy without achievement of glycemic control
Outpatients

Exclusion Criteria:

Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
Significant cardiovascular diseases
Significant diabetic complications
Other protocol-defined exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238498

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CLAF237A1202
Study First Received:	October 12, 2005
Last Updated:	June 1, 2006
ClinicalTrials.gov Identifier:	NCT00238498
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:

Type 2 diabetes
vildagliptin
HbA1c

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