Overview
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.
Description
This study is a 52-week, Phase 2 trial is designed to examine whether treatment with icovamenib in participants with T2D who are currently on standard-of-care antihyperglycemic medications (metformin, SGLT2 inhibitor, alogliptin, or sitagliptin) plus lifestyle management will result in a greater reduction in HbA1c than those therapies alone. The trial investigates participants who have been on a stable dose of their antihyperglycemic medication(s) for at least 3 months prior to screening whose HbA1c remains above the target established by the American Diabetes Association (ADA).
Eligibility
Inclusion Criteria:
- Males or females, age ≥18 years and ≤70 years
- Diagnosed with T2D
- 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)
- Have HbA1c ≥7.5 and ≤10.5%
- Have a BMI ≤32 kg/m2
- 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.
- Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.
Exclusion Criteria:
- Have type 1 diabetes mellitus or a secondary form of diabetes
- Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening
- Have positive GAD autoantibody result at screening
- Have a history of severe hypoglycemia (defined by the occurrence of hypoglycemia symptoms requiring the assistance of another person for recovery) in the 6 months prior to screening or a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as judged by the investigator
- Have personal or family history (first-degree relative) of MEN16. Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, \[linagliptin, saxagliptin (these 2 are drugs within DPP4I class)\], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
- Have FPG ≥240 mg/dL
- Have fasting triglyceride ≥500 mg/dL
- Have an eGFR \<75 mL/min/1.73 m2 by the CKD-EPI Creatinine Equation at screening
- Have impaired liver function, defined as screening AST or ALT \>1.2×ULN, and/or total bilirubin \>ULN