Summary:
A Randomized, Placebo-Controlled, Double-Blind, Muticenter, Phase 2 Study to Assess Safety, Tolerability, and Renal Effects of TMX-049 in subjects with type II Diabetes and Albuminuria.
The randomized population will include males or females (using a highly effective birth control method or not of childbearing potential) who are at least 18 years of age, have Type 2 diabetes treated with ≥1 glucose-lowering medication for at least 12 months, UACR 200 to 3000 mg/g at Visit 1 and Visit 2, eGFR ≥30 ml/min/1.73m2 at Visit 1 and Visit 2, and have been treated with at least the minimal recommended dose of an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB), but not both, for at least 3 months prior to Visit 1, without any adjustments to this therapy for at least 4 weeks prior to the Visit 1. Compliance (based on pill count) of ≥80% during the 2-week single-blind, placebo run-in phase of the study is also required for inclusion.
Qualified Participants May Receive:
If qualified subjects will receeive excellent health care, medication, and will be compensated $50.00 for their time and travel.