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Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec
Sponsor: Diasome Pharmaceuticlas, Inc.
Summary
The goal of this study is to see if directing insulin to the liver will improve the low blood sugar that sometimes happens when injecting insulin in Type 1 diabetes patients. Participants will use continuous glucose monitoring to measure the sugar levels in their blood, and work with the doctor to find the best doses. One group of patients will get the liver targeting insulin, and the other group will use insulin they normally use for treating Type 1 diabetes. The participant will be part of the study for up to 32 weeks.
Official title: A Phase 2b Randomized, Double-blind Trial Comparing HDV-Insulin Lispro Versus Insulin Lispro Alone in Adults With Type 1 Diabetes Receiving Insulin Degludec
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
227
Start Date
2024-01-23
Completion Date
2025-12
Last Updated
2025-08-19
Healthy Volunteers
No
Conditions
Interventions
HDV-Lispro
HDV-L will be used as the mealtime insulin
Lispro
Lispro will be used as the mealtime insulin
Locations (27)
Marvel Clinical Research
Huntington Beach, California, United States
Pasadena Clinical Trials
Pasadena, California, United States
Diabetes Research Center
Tustin, California, United States
University of Colorado, Barbara Davis Center
Denver, Colorado, United States
East Coast Institute for Research
Jacksonville, Florida, United States
University of Miami Diabetes Research Institute
Miami, Florida, United States
Metabolic Research Institute
West Palm Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
East Coast Institute for Research
Canton, Georgia, United States
Physicians Research Associates, LLC
Lawrenceville, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
University of Chicago Kovler Diabetes Center
Chicago, Illinois, United States
Endeavor Health
Skokie, Illinois, United States
Indiana Medical Research Institute
Merrillville, Indiana, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Asheville Clinical Research
Asheville, North Carolina, United States
UNC EnDO Clinical Research Unit
Chapel Hill, North Carolina, United States
Physician's East
Greenville, North Carolina, United States
University Hospitals Medical Center
Cleveland, Ohio, United States
Texas Diabetes & Endocrinology
Austin, Texas, United States
Tekton Research, LLC
Irving, Texas, United States
Tekton Research, LLC
McKinney, Texas, United States
Texas Diabetes % Endocrinology
Round Rock, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Tekton Research, LLC
San Antonio, Texas, United States
Wasatch Clinical Research, LLC 310
Salt Lake City, Utah, United States
Virginia Endocrinology Research
Chesapeake, Virginia, United States