Type 2 Diabetes Mellitus
Conditions
Interventions
investigational material(s)
Generic name etc : Dapagliflozin 5 mg
INN of investigational material : dapagliflozin
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Inve
Sponsors
AstraZeneca
Bristol-Myers Squibb
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Provision of informed consent prior to any study specific procedures -Diagnosis of Type 2 Diabetes according the criteria specified by the Japan Diabetes Society -Japanese Men or women age 20 years or more at time of consenting. -Stable (unless adjustment is required based on Fasting Plasma Glucose values) dose insulin mono-therapy with the mean insulin [up to two types of insulin within authorized indication in Japan] dose of 0.2 IU/kg/day or more AND 15 IU/body/day or more over the past 8 weeks prior to enrolment. -HbA1c 7.2% or more and < 11% from the blood samples collected at Visit 1 (enrolment) and Visit 3, observed from the central laboratory
Exclusion criteria
Exclusion criteria: -Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young, secondary diabetes mellitus or diabetes insipidus -History of diabetic ketoacidosis. -Thyroid-stimulating hormone and free T4 values outside normal range, observed from the central laboratory; an abnormal Thyroid-stimulating hormone value needs to be followed up with a free T4 test. Patients with abnormal free T4 values will be excluded at Visit 1 -Fasting Plasma Glucose >240 mg/dL (twice in a row) despite the permitted dose adjustment of insulin therapy during washout period and lead-in period. -Recent cardiovascular events in a patient. -eGFR 3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN, observed from the central laboratory at Visit 1. -Total bilirubin >2.0 mg/dL (34.2 micromol/L ), observed from the central laboratory at Visit 1. -Positive serologic evidence of current infectious liver disease including Hepatitis A viral antibody IgM, Hepatitis B surface antigen and Hepatitis C virus antibody, observed from the central laboratory. -Haemoglobin <10 g/dL (<100 g/L) or 6.2 mmol/L for men; haemoglobin <9.0 g/dL (<90 g/L) or 5.9 mmol/L for women, observed from the central laboratory at Visit 1. -History of chronic haemolytic anaemia or haemoglobinopathies (for example, sickle cell anaemia, thalassemia, sideroblastic anaemia). Mild haemolysis due to artificial heart valves or due to sickle cell trait is not an exclusion criterion except when haemoglobin levels are too low (as defined in haemoglobin criteria above). -History of malignancy within the last 5 years prior to enrolment, excluding successful treatment of basal or squamous cell skin cancer.
Outcome results
None listed