Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec
- Registration Number
- NCT06238778
- Lead Sponsor
- Diasome Pharmaceuticlas, Inc.
- Brief 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.
- Detailed Description
Individuals age 18 up to 80 years with Type 1 diabetes using multiple daily injections of bolus insulin plus basal insulin will be enrolled into a double-blind randomized controlled trial to assess the efficacy, safety, and tolerability of Hepatocyte-Directed Vesicles-insulin lispro (HDV-L) versus lispro alone (LIS) used in combination with insulin degludec. The study includes (1), a screening period up to 3 weeks, (2), a Run-in Period of 2 weeks to assess eligibility and to transition to use of insulin lispro and insulin degludec and unmasked continuous glucose monitoring (CGM), )3), a 12-week dose optimization period to optimize bolus and basal insulin doses,, (4), a 13-week maintenance period, and (5), a 2 -week transition follow-up period.
The primary objective of the study is to determine if the addition of HDV to insulin lispro results in an improvement in glycemic control as defined by decreasing evidence of nocturnal hypoglycemia while maintaining or improving glycated hemoglobin (HbA1c). Other outcomes related to glycemic control will also be evaluated.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 230
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HDV Lispro (HDV-L) HDV-Lispro Subjects in this arm will use degludec as their daily basal insulin, and HDV-lispro as their bolus insulin Lispro (LIS) Lispro Subjects in this arm will use degludec as their daily basal insulin and lispro as their bolus insulin
- Primary Outcome Measures
Name Time Method hypoglycemia percentage of time during the first 6 weeks of maintenance period CGM-measured nocturnal percent time
hypoglycemia events during the first 6 weeks of the maintenance period CGM-measured rates of nocturnal level 2 hypoglycemia events
- Secondary Outcome Measures
Name Time Method blood chemistry values baseline through study completion, an average of 7 months Triglyceride levels, Liver enzymes
Trial Locations
- Locations (24)
Diabetes Research Center
🇺🇸Tustin, California, United States
East Coast Institute for Research
🇺🇸Canton, Georgia, United States
Physicians Research Associates, LLC
🇺🇸Lawrenceville, Georgia, United States
University of Chicago Kovler Diabetes Center
🇺🇸Chicago, Illinois, United States
Physician's East
🇺🇸Greenville, North Carolina, United States
Wasatch Clinical Research, LLC 310
🇺🇸Salt Lake City, Utah, United States
Virginia Endocrinology Research
🇺🇸Chesapeake, Virginia, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
Pasadena Clinical Trials
🇺🇸Pasadena, California, United States
University of Colorado, Barbara Davis Center
🇺🇸Denver, Colorado, United States
University of Miami Diabetes Research Institute
🇺🇸Miami, Florida, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
Metabolic Research Institute
🇺🇸West Palm Beach, Florida, United States
UNC EnDO Clinical Research Unit
🇺🇸Chapel Hill, North Carolina, United States
University Hospitals Medical Center
🇺🇸Cleveland, Ohio, United States
Texas Diabetes & Endocrinology
🇺🇸Austin, Texas, 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
Tekton Research, LLC
🇺🇸San Antonio, Texas, United States
Texas Diabetes % Endocrinology
🇺🇸Round Rock, Texas, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States