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Clinical Trial Details

Trial ID: L5288
Source ID: NCT06152042
Associated Drug: Bmf-219
Title: Phase 2 Trial of BMF-219 in Participants with Type 1 Diabetes Mellitus
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: BMF-219
Outcome Measures: Primary: To assess the effect on endogenous insulin secretion, Mean change from baseline in stimulated C-peptide AUC., 26 Weeks | Secondary: To assess the effect on endogenous insulin secretion, Maximum stimulated C-peptide: the highest value at any time point during the 4-hour MMTT., 26 Weeks|To assess the effect on additional glycemic parameters, Mean change from baseline in HbA1c., 26 Weeks of treatment|To assess the effect on additional glycemic parameters, Mean change from baseline in FPG., 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., 26 weeks|To assess the effect on insulin doses, Change from baseline in mean daily insulin dosing., 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., 26 Weeks and during study duration|Incidence of adverse events, Evaluation and comparison of the number of adverse events with BMF-219 vs placebo during the study., 26 Weeks and during study duration
Sponsor/Collaborators: Sponsor: Biomea Fusion Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 190
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-28
Completion Date: 2025-08-31
Results First Posted:
Last Update Posted: 2024-10-26
Locations: Sutter Valley Medical Foundation Pediatric Endocrinology, Sacramento, California, 95821, United States|Diablo Clinical Research,Inc, Walnut Creek, California, 94598, United States|Southwest General Healthcare Center, Fort Myers, Florida, 33907, United States|Suncoast Clinical Research, Inc., New Port Richey, Florida, 34652, United States|Oceanic Research Group, North Miami Beach, Florida, 33169, United States|Metabolic Research Institute, West Palm Beach, Florida, 33401, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|Centricity Research, Columbus, Georgia, 31904, United States|Washington University in St. Louis, Saint Louis, Missouri, 63110, United States|Palm Research Center, Las Vegas, Nevada, 89148, United States|Lucas Research, Inc., Morehead City, North Carolina, 28577, United States|Accellacare of Wilmington, Wilmington, North Carolina, 28401, United States|Diabetes and Endocrinology Center, Winston-Salem, North Carolina, 27104, United States|Alliance for Multispecialty Research, Norman, Oklahoma, 73069, United States|University Diabetes & Endocrine Consultants, Chattanooga, Tennessee, 37411, United States|Velocity Clinical Research, Dallas, Texas, 75230, United States|UT Southwestern Medical Center, Dallas, Texas, 75390, United States|Diabetes and Thyroid Center of Fort Worth, Fort Worth, Texas, 76132, United States|PlanIt Research, PLLC, Houston, Texas, 77079, United States|Tekton Research, McKinney, Texas, 75069, United States|Texas Diabetes & Endocrinology, Round Rock, Texas, 78681, United States|Clinical Trials of Texas, San Antonio, Texas, 78229, United States|Diabetes & Glandular Disease Clinic, P.A., San Antonio, Texas, 78229, United States|Endeavor Clinical Trials, LLC, San Antonio, Texas, 78229, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|BC Diabetes, Vancouver, British Columbia, Canada|Centricity Research, Brampton, Ontario, L6S 0C6, Canada|Centricity Research, Ottawa, Ontario, K2J 0V2, Canada|Centricity Research, Toronto, Ontario, Canada
URL: https://clinicaltrials.gov/show/NCT06152042

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress