DELIGHT
- Conditions
- Type 2 Diabetes Mellitus, CKD and Albuminuria
- Registration Number
- JPRN-jRCT2080223076
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 75
Provision of informed consent prior to any study specific procedures
- History of type 2 diabetes mellitus for more than 12 months
- HbA1c 7.0% or more and less than 11.0%
- Stable antidiabetic treatment during the last 12 weeks up to randomization
- eGFR 25-75mL/minute/1.73m2, inclusive
- Micro or macroalbuminuria (UACR 30 - 3500mg/g)
- Treatment with ACE inhibitor or an ARB for at least 3 months prior to screening
- Body mass index between 20 and 45kg/m2
- 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) >2mg/dL (34.2 micro mol/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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method