Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBiomea Fusion Inc.
About this trial
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
Qualifiers
Males or females, age ≥18 years and ≤75 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 (if participants are taking metformin they must be on a minimum stable dose of ≥500 mg/day)
Have HbA1c ≥7.5 and ≤10.5%
Disqualifiers
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 within 60 days prior to 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
Trial design
Treatments tested in this trial
- icovamenib 100mg
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov