Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria

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.

Key Inclusion Criteria:

- 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.

Key Exclusion Criteria:

- 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