NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080223014

Registered date:13/11/2015

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedType 2 Diabetes Mellitus
Date of first enrollment13/11/2015
Target sample size335
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : DS-8500a INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : Sitagliptin INN of investigational material : Sitagliptin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary OutcomeChange from baseline in HbA1c
Secondary Outcome-Change from baseline (Day -1) in HbA1c at Weeks 4 and 8 -Proportion of subjects who have achieved HbA1c of < 7.0% at Weeks 4, 8, and 12 -Change from baseline (Day -1) in fasting blood glucose at Weeks 2, 4, 8, and 12

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaMain Inclusion Criteria; 1)Patients aged >= 20 years 2)Japanese patients with type 2 diabetes mellitus 3)Patients who have >= 7.0% and < 10.0% HbA1c
Exclude criteriaMain Exclusion Criteria; -Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis -Patients receiving or requiring treatment with insulin -Patients with a body mass index (BMI) of < 18.5 kg/m2 or >= 35.0 kg/m2 -Patients with clinically evident renal impairment (estimated glomerular filtration rate [eGFR] of < 45 mL/min per 1.73 m2) or clinically significant renal disease -Patients with fasting plasma glucose >= 240 mg/dL

Related Information

Contact

Public contact
Name
Address http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
Telephone
E-mail
Affiliation DAIICHI SANKYO Co.,Ltd
Scientific contact
Name
Address
Telephone
E-mail
Affiliation