NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 Diabetes Mellitus
Date of first enrollment	20/01/2016
Target sample size	90
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

Outcome(s)

Primary Outcome

Change from baseline in 24hr-weighted mean glucose

Secondary Outcome

-Change from baseline (Day -1) in fasting plasma glucose -Change in plasma glucose, glycoalbumin, serum insulin, proinsulin, C-peptide, PYY, total GLP-1, active GLP-1, total GIP, and glucagon at each matched time point from baseline (Day -1) -Change in pharmacodynamic parameters including plasma glucose, serum insulin, C-peptide, PYY, total GLP-1, active GLP-1, total GIP, and glucagon from baseline (Day -1) to Day 28 -Change from baseline (Day -1) in total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	Main Inclusion Criteria; 1)Japanese patients with type 2 diabetes mellitus 2)Patients aged >= 20 years 3)Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus 4)Patients who have >= 7.0% and < 9.0% 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