NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080220326

Registered date:29/11/2006

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedType 2 Diabetes
Date of first enrollment29/11/2006
Target sample size150
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : Vildagliptin INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary OutcomePrimary Adverse events profile after 52 weeks of treatment Secondary Outcomes: 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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
Gender
Include criteriaInclusion Criteria: - Diagnosis of type 2 diabetes - Patients who have completed study CLAF237A1303 - Outpatients Exclusion Criteria: - Patients who prematurely discontinued Study CLAF237A1303 Other protocol-defined inclusion/exclusion criteria may apply
Exclude criteria

Related Information

Contact

Public contact
Name
Address 0120-003-293
Telephone
E-mail
Affiliation Novartis Pharma KK
Scientific contact
Name
Address
Telephone
E-mail
Affiliation