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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT03504566
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes
* eGFR \> 45ml/min/1.73m2
* Albumin:creatinine ratio \>50mg/g and ≤500 mg/g
* Age ≥ 18 years
* Written informed consent
Exclusion Criteria:
* Pregnant women and women of child-bearing potential who are not using reliable contraception . In addition, fertile women included in the trial must use contraceptive methods in line with the below throughout the entire trial period and until the end of relevant systemic exposure for human teratogenicity/fetal toxicity. Approved contraceptives are intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release).
* Cardiovascular disease: myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV) \< 6 months before inclusion
* Uncontrolled blood pressure (office BP \> 160/100 mmHg)
* Active malignancy
* History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension)
* Participation in any clinical investigation within 3 months prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
* Hypersensitivity to study drugs and their excipients
* Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing
* History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
* Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
* Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
* Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
* Pancreatic injury or pancreatitis within the last six months;
* Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt;
* Evidence of urinary obstruction of difficulty in voiding at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03504566
Study Brief:
Protocol Section:
NCT03504566