Phase 2 Trial of BMF-219 in Participants with Type 1 Diabetes Mellitus.
Study COVALENT-112 is a 52-week, Phase 2 trial designed to examine beta-cell function, insulin sensitivity, and both glucose and lipid metabolism in participants with T1D treated with BMF-219. BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
37
BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.
Oceanic Research Group
North Miami Beach, Florida, United States
Lucas Research, Inc.
Morehead City, North Carolina, United States
Alliance for Multispecialty Research, LLC.
Norman, Oklahoma, United States
To assess the effect on endogenous insulin secretion
Mean change from baseline in stimulated C-peptide AUC.
Time frame: 26 Weeks
To assess the effect on endogenous insulin secretion
Maximum stimulated C-peptide: the highest value at any time point during the 4-hour MMTT.
Time frame: 26 Weeks
To assess the effect on additional glycemic parameters
Mean change from baseline in HbA1c.
Time frame: 26 Weeks of treatment
To assess the effect on additional glycemic parameters
Mean change from baseline in FPG.
Time frame: 26 Weeks
To assess hypoglycemia events
Percentage of participants with hypoglycemic episodes (with confirmed self-plasma glucose monitoring) including level 2 hypoglycemic events (\<54 mg/dL regardless of symptoms) and level 3 (severe) hypoglycemia across different timepoints.
Time frame: 26 weeks
To assess the effect on insulin doses
Change from baseline in mean daily insulin dosing.
Time frame: 26 Weeks
Rate of symptomatic hypoglycemic episodes
Evaluation and comparison of the number of symptomatic (both minor and severe) hypoglycemic episodes with BMF-219 vs placebo during the study.
Time frame: 26 Weeks and during study duration
Incidence of adverse events
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University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, United States
Velocity Clinical Research
Dallas, Texas, United States
Texas Diabetes & Endocrinology
Round Rock, Texas, United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Dr. T.G Elliott Inc. dba BC Diabetes
Vancouver, British Columbia, Canada
...and 1 more locations
Evaluation and comparison of the number of adverse events with BMF-219 vs placebo during the study.
Time frame: 26 Weeks and during study duration