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Keep this study
Lead
Calliditas Therapeutics AB
A double-blind, placebo-controlled, randomized, multicenter, parallel group Phase 2 study assessing a 12-week period of treatment with oral GKT137831 administered in addition to standard of care for patients with type 2 diabetes.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female aged 18 to 80 years
History of type 2 diabetes, defined as fasting plasma glucose ≥7.0 mmol/L (126 mg/dL) or a glycated hemoglobin (HbA1c) \>6.5% (48 mmol/mol) on at least 2 occasions prior to screening.
Albuminuria defined as a UACR of 300 to 3500 mg/g.
An eGFR ≥30 mL/min/1.73 m2, as calculated by the CKD-EPI formula.
Must be taking an ACEI or an ARB for at least 6 weeks prior to the first screening visit (Visit 1) and during the screening period. The dose must have been stable for at least 4 weeks prior to the first screening visit (Visit 1). Combination therapy associating an ACEI and an ARB is not permitted.
You may not be if
History of type 1 diabetes
Any other non-diabetic kidney disease(s) except for hypertensive nephropathy which is acceptable.
Diagnostic or interventional procedure requiring a contrast agent within 4 weeks of the first screening visit (Visit 1) or planned during the study.
History of renal transplant or planned renal transplant during the study.
A history of acute renal dialysis or acute kidney injury (defined according to the Kidney Disease: Improving Global Outcomes \[KDIGO\] definition) within 12 weeks of the first screening visit (Visit 1)
HbA1c level \>11% (97 mmol/mol).
History of hypothyroidism requiring hormone replacement therapy.
History of active cardiovascular disease
A personal or family history of long QT syndrome.
Administration of any investigational product within 30 days or within 5 half-lives of the investigational agent
Clareo Health | Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
