Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Female or male aged ≥18 years and \<75 years.
History of T2DM for more than 12 months.
Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11%
Stable anti-diabetic treatment regimen
Renal impairment: CKD 3A
You may not be if
Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or Diastolic Blood Pressure (DBP) ≥110 mmHg
Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to signing the consent at visit 1:
Myocardial infarction, Cardiac surgery or revascularization(CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.
History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
Ongoing treatment with any SGLT2-inhibitor, GLP-1 analogue, or rapid/short acting insulins at screening.
Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1.
