Type 2 Diabetes MedDRA version: 12.0 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus
Conditions
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must be willing and able to give signed and dated written informed consent. 2) Subjects must have type 2 diabetes with inadequate glycemic control, defined as central laboratory HbA1c = 6.6% and = 9.5% obtained at the enrollment visit. 3) Subjects should have been receiving metformin (XR or IR) and/or SU for at least 4 weeks prior to enrollment at any stable dose. Stable dose is defined as a dose that has remained the same for at least 4 weeks prior to the enrollment visit (i.e., same prescribed total daily dose). 4) Subjects must have inadequate BP control, defined as seated SBP = 130 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period. 2) Women who are pregnant or breastfeeding. 3) Women with a positive pregnancy test on enrollment or prior to investigational product administration and/or injection of iohexol, and, for subjects participating in the substudy, prior to administration of radioisotopes for determination of RCM and PV. 4) Estimated GFR (eGFR) by the Modification of Diet in Renal Disease (MDRD) formula = 60 mL/min/1.73m2 and = 150 mL/min/1.73m2. 5) Urine albumin to creatinine ratio (UACR) = 300 mg/g (33.9 mg/mmol/Cr). 6) Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN). 7) Alanine aminotransferase (ALT) > 3X ULN. 8) Serum Total Bilirubin > 2 mg/dL (34.2 µmol/L). 9) Serum Creatinine (Scr) = 1.50 mg/dL (133 µmol/L) for men; SCr = 1.40 mg/dL (124 µmol/L) for women. 10) Hemoglobin = 10.0 g/dL (100 g/L) for men; hemoglobin = 9.0 g/dL (90 g/L) for women. 11) Creatine kinase (CK) > 3X ULN. 12) Positive for hepatitis B surface antigen. 13) Positive for anti-hepatitis C virus antibody. 14) Abnormal free T4 value. 15) History of diabetes insipidus. 16) Symptoms of poorly controlled diabetes that would preclude participation in this trial including, but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to enrollment, or other signs and symptoms. 17) History of diabetic ketoacidosis or hyperosmolar nonketotic coma. 18) Myocardial infarction. 19) Cardiac surgery or revascularization (coronary artery bypass surgry [CABG]/ percutaneous transluminal coronary angioplasty [PTCA]). 20) Unstable angina. 21) Unstable congestive heart failure (CHF). 22) CHF New York Heart Association (NYHA) Class III or IV. (see Appendix 3 of the protocol) 23) Transient ischemic attack (TIA) or significant cerebrovascular disease. 24) Unstable or previously undiagnosed arrhythmia. 25) History of malignant or accelerated hypertension. 26) History of gout. 27) History of unstable or rapidly progressing renal disease. 28) Conditions of congenital renal glucosuria. 29) Significant hepatic disease, including but not limited to, chronic active hepatitis and/or severe hepatic insufficiency. 30) Documented history of hepatotoxicity with any medication. 31) Documented history of severe hepatobiliary disease. 32) History of hemoglobinopathy, with the exception of sickle cell trait (SA) or thalassemia minor; or chronic or recurrent hemolysis. 33) Donation of blood or blood products to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 6 weeks prior to the enrollment visit. 34) Malignancy within 5 years of the enrollment visit (with the exception of treated basal cell or treated squamous cell carcinoma of the skin). 35) Known immunocompromised status, including but not limited to, individuals who have undergone organ transplantation or who are positive for the human immunodeficiency virus. 36) Allergies or contraindication to the contents of dapagliflozin tablets. 37) History of adverse reaction to radio-contrast dye. 38) Allergy or contraindication to use of thiazide diuretics. 39) Administration of insulin or any other antihyperglycemic therapy (other than metformin and/or SU), at any dose and time, during the 4 weeks prior to the enrollment visit. 40) Administration of any diuretics or other drugs approved for the treatment of hypertension (with the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: This study has no primary or secondary objectives.;Primary end point(s): The primary endpoint is the percent change from baseline in GFR, as determined by plasma clearance of nonradioactive iohexol, after 12 weeks of dapagliflozin administration.;Main Objective: Research Hypothesis: There is no formal research hypothesis for this study. This study will evaluate the percent change from baseline in GFR with dapagliflozin plus metformin and/or a sulfonylurea (SU) versus placebo plus metformin and/or SU, after 12 weeks of oral double-blind treatment. This study has no primary or secondary objectives. | — |
Countries
Netherlands
Outcome results
None listed