NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 Diabetes Mellitus
Date of first enrollment	13/11/2015
Target sample size	335
Countries of recruitment
Study type	Interventional
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 Outcome	Change 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 maximum	Not applicable
Gender	Both
Include criteria	Main 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 criteria	Main 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