NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 Diabetes Mellitus
Date of first enrollment	28/09/2009
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Dapagliflozin (BMS-512148) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Once daily, 12 weeks control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Once daily, 12 weeks

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 79age old
Gender	Both
Include criteria	- Japanese Subjects with type 2 diabetes mellitus. - Strictly/relatively treatment naive Subjects with HbA1c (7.0% to 10%), or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c (8% or less). - Provision of informed consent.
Exclude criteria	- Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease. - The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.