Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
Trial Parameters
Brief Summary
This is a Phase 2, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes who are not achieving glycemic targets despite antihyperglycemic medications.
Eligibility Criteria
Inclusion Criteria: 1. Males or females, age ≥18 years and ≤70 years 2. Diagnosed with T2D 3. Have been treated with lifestyle management with 1 to 3 antihyperglycemic medications: metformin, SGLT2i, alogliptin, or sitagliptin with a stable dose for at least 3 months prior to screening (participants taking metformin must be on a minimum stable dose of ≥500 mg/day) 4. Have HbA1c ≥7.5 and ≤10.5% 5. Have a BMI ≤32 kg/m2 6. Female participants of childbearing potential must have a negative pregnancy test, must be non-lactating and must be willing to have additional pregnancy tests during the study. 7. Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests. Exclusion Criteria: 1. Have type 1 diabetes mellitus or a secondary form of diabetes 2. Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening 3. Have positive GAD autoantibody result at screening 4. Have a history of seve