NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080221679

Registered date:21/12/2011

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedType 2 diabetes mellitus
Date of first enrollment21/12/2011
Target sample size136
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : LAF237 INN of investigational material : Vildagliptin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Twice daily, oral control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Twice daily, oral

Outcome(s)

Primary OutcomeHbA1c
Secondary OutcomeHbA1c, Fasting plasma glucose, Safety

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 74age old
GenderBoth
Include criteria- Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy - HbA1c in the range of 7.0-10.0% - Body mass index in the range 20-35 kg/m2
Exclude criteria- Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes - Significant heart diseases

Related Information

Contact

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