Type 2 Diabetes and Albuminuria
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -The subject signs and dates a written, informed consent form prior to the initiation of any study procedures -The subject is capable of understanding and complying with protocol requirements -The subject is either male or female and aged 18 to 75 years (inclusive) at signing of informed consent -The subject has been treated with stable doses of the same RAS inhibitors for at least 3 months prior to Visit 1 -The subject has been treated with stable doses of AHA monotherapy or combination therapy for at least 3 months prior to Visit 1 -The subject has UACR >=200 mg/gCr to <5000 mg/gCr -The subject has a HbA1c =< 10.5%
Exclusion criteria
Exclusion criteria: -The subject has a history of type 1 diabetes mellitus -The subject has a confirmed diagnosis of a renal disease other than type 2 DKD (eg, lupus nephritis, primary focal segmental glomerulosclerosis, acute or chronic glomerular nephritis, bilateral or unilateral renal artery stenosis or polycystic kidney disease). Concomitant hypertensive nephrosclerosis is not prohibited
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety exploratory -Incidence and severity of adverse events (AE) -Incidence of serious adverse events -Clinically significant changes from baseline in -Clinical laboratory tests -12-lead electrocardiograms -vital signs -physical examinations -Incidence and severity of hypoglycemia and hyperglycemia efficacy exploratory Change in log-transformed UACR from baseline at the ompletion of the treatment period (Week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy exploratory Change in eGFR value from baseline at the completion of the treatment period (Week 12). efficacy exploratory Responder rate (UACR decreased by>= 30%) from baseline at the completion of the treatment period (Week 12). | — |
Countries
Oceania