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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
icovamenib 100mg
Matching placebo
Central Research Associates, LLC dba Flourish Research
Birmingham, Alabama, United States
Hope Clinical Research
Canoga Park, California, United States
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
Mean change in HbA1c from baseline
Time frame: 26 weeks
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
Mean change in HbA1c from baseline
Time frame: 12 weeks
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
Mean change in HbA1c from baseline
Time frame: 52 weeks
To compare the change in fasting plasma glucose with icovamenib versus placebo during the off-treatment Follow-up Period
Mean change in fasting plasma glucose from baseline
Time frame: 26 weeks
To compare the safety and tolerability of icovamenib versus placebo
Incidence of AEs
Time frame: 52 weeks
To compare the safety and tolerability of icovamenib versus placebo
Incidence of TEAEs
Time frame: 52 weeks
To compare the safety and tolerability of icovamenib versus placebo
Incidence of SAEs
Time frame: 52 weeks
To compare the safety and tolerability of icovamenib versus placebo
Incidence of early discontinuation of trial intervention due to TEAEs
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Ark Clinical Research
Fountain Valley, California, United States
Ark Clinical Research
Long Beach, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Paradigm Clinical Research Centers, LLC
San Diego, California, United States
Southwest General Healthcare Center
Fort Myers, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States
David Kavtaradze MD, Inc
Cordele, Georgia, United States
...and 8 more locations
Time frame: 12 weeks