NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	type 2 diabetes
Date of first enrollment	09/07/2010
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : OPC-262 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : OPC-262 5mg will be administered before breakfast for 14 consecutive days

Outcome(s)

Primary Outcome	Pharmacokinetics 1) Plasma saxagliptin concentration 2) Plasma BMS-510849 concentration
Secondary Outcome	Pharmacodynamics 1) Plasma DPP4 activity 2) Blood glucose level 3) Blood C-peptide concentration 4) Blood insulin concentration 5) Blood glucagon concentration 6) Plasma active GLP-1 concentration

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 65age old
Gender	Both
Include criteria	Patients who meet all of the following criteria will be included: 1) HbA1c level equal or more than 7.0 % and less than 9.0 % 2) Fasting glucose level equal or more than 130 mg/dL and less than 210 mg/dL 3) Patients who are capable of giving informed consent 4) Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after completion of the study
Exclude criteria	1) Patients with type 1 diabetes mellitus; patients with diabetes mellitus due to other specified drugs, mechanisms, or diseases; and patients with gestational diabetes mellitus 2) Patients with a medical history of diabetic coma 3) Patients with heart failure 4) Patients with a complication of active chronic hepatitis or hepatic cirrhosis 5) Patients undergoing treatment of glomerular diseases other than diabetic nephropathy 6) Patients with a history or complication of malignant tumor