Phase 2 Study of Icovamenib Added to Usual Diabetes Medicines for Adults With Type 2 Diabetes Not Reaching Blood Sugar Goals Despite Treatment

What this Trial Is About

This trial evaluates icovamenib in adults with Type 2 Diabetes who have not met blood sugar goals despite using standard antihyperglycemic medications. It is a Phase 2, randomized, double-blind, placebo-controlled study that aims to assess whether icovamenib can better reduce HbA1c compared to current therapies. Participants are adults aged 18 to 75 years with stable antihyperglycemic treatment and HbA1c above the target set by the American Diabetes Association. Participants are randomly assigned to receive either icovamenib 100 mg once daily or a matching placebo for 12 weeks, in addition to their prescribed antihyperglycemic medications such as metformin, SGLT2 inhibitors, alogliptin, or sitagliptin. After this 12-week treatment period, they continue their usual antihyperglycemic medications without study drug for the remaining duration of the trial, totaling approximately 56 weeks. During the study, participants undergo assessments of blood sugar control, including HbA1c levels, fasting plasma glucose, and safety evaluations throughout the 52-week trial period. Researchers will monitor tolerability, changes in glycemic control, and adverse effects. Participants provide informed consent and comply with study procedures, including regular visits and laboratory tests, to help determine the effects and safety of icovamenib compared to placebo.

Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets