NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080221168

Registered date:23/07/2010

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedType 2 diabetes mellitus patients whose blood glucose levels are not adequately controlled by pioglitazone in addition to diet and exercise therapies
Date of first enrollment23/07/2010
Target sample size120
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : SMP-508 (repaglinide) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary OutcomeEfficacy: HbA1C etc
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaPatients with type 2 diabetes mellitus who meet the following requirements -Patients who have been on a fixed regimen of diet and exercise therapies -Patients who have been taking pioglitazone continuously at a fixed dose -Patients whose HbA1C level is 6.5% <= HbA1C <= 9.0% and is stable over 4 weeks -Patients aged 20 or older -Outpatients etc.
Exclude criteria-Patients with hepatic dysfunction -Patients with renal dysfunction -Patients with cardiac diseases -Patients with severe hypertension etc.

Related Information

Contact

Public contact
Name
Address http://www.ds-pharma.com/inquiry/index.html
Telephone
E-mail
Affiliation Dainippon Sumitomo Pharma Co., Ltd.
Scientific contact
Name
Address http://www.ds-pharma.com/inquiry/index.html
Telephone
E-mail
Affiliation Dainippon Sumitomo Pharma Co., Ltd.