A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
18–130
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Provision of informed consent prior to any study specific procedures
Female or male aged ≥18 years
History of type 2 diabetes mellitus for more than 12 months
HbA1c≥7.0% and ≤11.0%
Stable antidiabetic treatment during the last 12 weeks up to randomization
eGFR 25-75 mL/minute/1.73m2, inclusive
Micro or macroalbuminuria (UACR 30 - 3500 mg/g)
Treatment with ACE inhibitor or an ARB for at least 3 months prior to screening
Body mass index between 20 and 45 kg/m2
You may not be if
Any of the following CV/Vascular Diseases within 3 month prior to signing the consent at Visit 1:
* Myocardial infarction
* cardiac surgery or revascularization (CABG/PTCA)
* unstable angina
* unstable HF
* New York Heart Association (NYHA) Class III-IV
* transient ischemic attack (TIA) or significant cerebrovascular disease
* unstable or previously undiagnosed arrhythmia
Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency
Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 3X ULN
Total Bilirubin (TB) \>2 mg/dL (34.2 μmol/L)
History of acute kidney injury requiring renal replacement therapy (dialysis or ultrafiltration) or any biopsy or imaging verifying intercurrent kidney disease other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis
Ongoing treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors
Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance
Clareo Health | A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD
