A Study To Compare the Effect of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00351832

Purpose

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg bid or 100mg qd compared to placebo in patients with type 2 diabetes.

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

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, Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin (50mg qd, 50mg Bid, 100mg qd) to Placebo in Patients With Type 2 Diabetes

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline on HbA1c at 12 weeks

Secondary Outcome Measures:

Change from baseline on fasting plasma glucose at 12 weeks
Change from baseline on HOMA B at 12 weeks
Change from baseline on HOMA IR at 12 weeks
Change from baseline in body weight at 12 weeks
Change from baseline on fasting lipids at 12 weeks

Estimated Enrollment:	236
Study Start Date:	June 2006

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Diagnosis of type 2 diabetes
Patients who have been placed on dietary therapy/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 disease
Significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351832

Locations

Japan
Novartis Pharmaceuticals
Tokyo, Japan

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CLAF237A1303
Study First Received:	July 11, 2006
Last Updated:	May 7, 2007
ClinicalTrials.gov Identifier:	NCT00351832
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Type 2 diabetes
Vildagliptin
Hemoglobin A1c

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