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

NCT06238778 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: DP 01-2023-01
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 27

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus Type 1; CGM; Randomized; HDV; Lispro

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• blood chemistry values

  baseline through study completion, an average of 7 months

Study Arms (2)

HDV Lispro (HDV-L)

EXPERIMENTAL

Subjects in this arm will use degludec as their daily basal insulin, and HDV-lispro as their bolus insulin

Drug: HDV-Lispro

Lispro (LIS)

ACTIVE COMPARATOR

Subjects in this arm will use degludec as their daily basal insulin and lispro as their bolus insulin

Drug: Lispro

Interventions

HDV-Lispro DRUG

HDV-L will be used as the mealtime insulin

Also known as: HDV-L

HDV Lispro (HDV-L)

Lispro DRUG

Lispro will be used as the mealtime insulin

Also known as: LIS

Lispro (LIS)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Diasome Pharmaceuticlas, Inc.: lead

Study Sites (27)

Marvel Clinical Research

Huntington Beach, California, 92647, United States

Location

Pasadena Clinical Trials

Pasadena, California, 91101, United States

Location

Diabetes Research Center

Tustin, California, 92780, United States

Location

University of Colorado, Barbara Davis Center

Denver, Colorado, 80045, United States

Location

East Coast Institute for Research

Jacksonville, Florida, 32216, United States

Location

University of Miami Diabetes Research Institute

Miami, Florida, 33136, United States

Location

Metabolic Research Institute

West Palm Beach, Florida, 33401, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

East Coast Institute for Research

Canton, Georgia, 30114, United States

Location

Physicians Research Associates, LLC

Lawrenceville, Georgia, 30046, United States

Location

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076, United States

Location

University of Chicago Kovler Diabetes Center

Chicago, Illinois, 60637, United States

Location

Endeavor Health

Skokie, Illinois, 60077, United States

Location

Indiana Medical Research Institute

Merrillville, Indiana, 46410, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Asheville Clinical Research

Asheville, North Carolina, 28803, United States

Location

UNC EnDO Clinical Research Unit

Chapel Hill, North Carolina, 27514, United States

Location

Physician's East

Greenville, North Carolina, 27834, United States

Location

University Hospitals Medical Center

Cleveland, Ohio, 44106, United States

Location

Texas Diabetes & Endocrinology

Austin, Texas, 78749, United States

Location

Tekton Research, LLC

Irving, Texas, 75039, United States

Location

Tekton Research, LLC

McKinney, Texas, 75069, United States

Location

Texas Diabetes % Endocrinology

Round Rock, Texas, 78681, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Tekton Research, LLC

San Antonio, Texas, 78251, United States

Location

Wasatch Clinical Research, LLC 310

Salt Lake City, Utah, 84107, United States

Location

Virginia Endocrinology Research

Chesapeake, Virginia, 23321, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ruth Weinstock, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Enrolled subjects randomized to either the treatment arm or the control arm. The patient, the study site personnel, the CRO, and the sponsor are blinded to which group the patient is randomized to. Only the site pharmacist, and one study monitor from the CRO are unblinded. The Medical Monitor is blinded unless there is a medical reason for unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double blind interventional study

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 2, 2024
• Study Start: January 23, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)