Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00389415

Purpose

This 52-week multicenter open-labeled extension study is designed to assess the long-term safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is open to patients who have completed core study CLAF237A1303.

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, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Multicenter, Open, Long Term Safety Study of 52 Weeks Treatment With Vildagliptin (100 mg qd) In Patients With Type 2 Diabetes (Extension Study of Study CLAF237A1303)

Further study details as provided by Novartis:

Primary Outcome Measures:

Adverse events profile after 52 weeks of treatment

Secondary Outcome Measures:

Change from baseline to endpoint on HbA1c at 52 weeks
Change from baseline to endpoint on fasting plasma glucose at 52 weeks
Change from baseline to endpoint in HOMA B at 52 weeks
Change from baseline to endpoint in HOMA IR at 52 weeks
Change from baseline to endpoint in body weight at 52 weeks

Estimated Enrollment:	150
Study Start Date:	October 2006

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis as Type 2 Diabetes
Patients who have completed study CLAF237A1303
Outpatients

Exclusion Criteria:

Patients who prematurely discontinued Study CLAF237A1303
Other protocol-defined inclusion/exclusioncriterial may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389415

Locations

Japan
Novartis Pharmaceuticals
Tokyo, Japan

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CLAF237A1303E1
Study First Received:	October 16, 2006
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00389415
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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 16, 2009