Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT02547935
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
130 Years
Study:
NCT02547935
Study Brief:
Protocol Section:
NCT02547935