NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080220283

Registered date:27/07/2006

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedType 2 Diabetes
Date of first enrollment27/07/2006
Target sample size236
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 Outcomes: Change from baseline on HbA1c at 12 weeks Secondary Outcomes: Change from baseline on fasting plasma glucose at 12 weeks; Change from baseline on HOMA-veta at 12 weeks; Change from baseline on HOMA-R at 12 weeks; Change from baseline in body weight at 12 weeks; Change from baseline on fasting lipids at 12 weeks
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaAges Eligible for Study: 20 Years and above, Genders Eligible for Study: Both Inclusion Criteria: - Diagnosis of type 2 diabetes - Patients who have been placed on diet and exercise therapy without achieving target blood glucose levels - Outpatients Exclusion Criteria: - Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes - Significant cardiovascular complications - Significant diabetic complications 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