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Clinical Trial Details

Trial ID: L6680
Source ID: NCT06238778
Associated Drug: Hdv-Lispro
Title: Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec
Acronym: OPTI-2
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: HDV-Lispro|DRUG: Lispro
Outcome Measures: Primary: hypoglycemia events, CGM-measured rates of nocturnal level 2 hypoglycemia events, during the first 6 weeks of the maintenance period|hypoglycemia percentage of time, CGM-measured nocturnal percent time, during the first 6 weeks of maintenance period | Secondary: blood chemistry values, Triglyceride levels, Liver enzymes, baseline through study completion, an average of 7 months
Sponsor/Collaborators: Sponsor: Diasome Pharmaceuticlas, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 230
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-23
Completion Date: 2025-12
Results First Posted:
Last Update Posted: 2024-12-10
Locations: Marvel Clinical Research, Huntington Beach, California, 92647, United States|Pasadena Clinical Trials, Pasadena, California, 91101, United States|Diabetes Research Center, Tustin, California, 92780, United States|University of Colorado, Barbara Davis Center, Denver, Colorado, 80045, United States|East Coast Institute for Research, Jacksonville, Florida, 32216, United States|University of Miami Diabetes Research Institute, Miami, Florida, 33136, United States|Metabolic Research Institute, West Palm Beach, Florida, 33401, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|East Coast Institute for Research, Canton, Georgia, 30114, United States|Physicians Research Associates, LLC, Lawrenceville, Georgia, 30046, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|University of Chicago Kovler Diabetes Center, Chicago, Illinois, 60637, United States|Endeavor Health, Skokie, Illinois, 60077, United States|Indiana Medical Research Institute, Merrillville, Indiana, 46410, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States|Asheville Clinical Research, Asheville, North Carolina, 28803, United States|UNC EnDO Clinical Research Unit, Chapel Hill, North Carolina, 27514, United States|Physician's East, Greenville, North Carolina, 27834, United States|University Hospitals Medical Center, Cleveland, Ohio, 44106, United States|Texas Diabetes & Endocrinology, Austin, Texas, 78749, United States|Tekton Research, LLC, Irving, Texas, 75039, United States|Tekton Research, LLC, McKinney, Texas, 75069, United States|Texas Diabetes % Endocrinology, Round Rock, Texas, 78681, United States|Clinical Trials of Texas, San Antonio, Texas, 78229, United States|Tekton Research, LLC, San Antonio, Texas, 78251, United States|Wasatch Clinical Research, LLC 310, Salt Lake City, Utah, 84107, United States|Virginia Endocrinology Research, Chesapeake, Virginia, 23321, United States
URL: https://clinicaltrials.gov/show/NCT06238778

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress