Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT06238778

Run by

Diasome Pharmaceuticals

People needed

227

Starts

2023-12-28

Expected to finish

2025-12-16

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• clinical diagnosis Type 1 diabetes with C-peptide <=0.6 ng/mL and using insulin for at least 6 months
• willing to use study provided insulin as the only bolus insulin and insulin degludec as the basal insulin
• willing to use CGM device throughout the study
• screening A1C >= 6.5% and <= 10.0% daily insulin dose <= 1.25 U/kg/day

You may not qualify if…

• known or specific allergy to any component of the study drug, the active comparator
• pregnant or breast-feeding, or plans to become pregnant at any time during duration of study
• current use of hydroxyurea
• use of noninsulin glucose-lowering medications other than metformin, weight loss medications or dietary supplements for weight loss within 30 days, or anticipated use during the course of the study
• received any investigational drug within prior 30 days
• Clinically significant abnormalities on screening laboratory testing including liver enzymes
• Presence of a medical condition or use of a medication that could compromise the results of the study or the safety of the subject (eg. alcohol or drug abuse, uncontrolled hypertension, history of transient ischemic attack or stroke within the last 12 months)
• employed by or having immediate family members employed by the sponsor or directly involved in conducting the clinical trial.

Where it is running

• 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

Full record on ClinicalTrials.gov

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