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

NCT ID: NCT06238778

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2025-12-31

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HDV Lispro (HDV-L)

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

Group Type: EXPERIMENTAL

HDV-Lispro

Intervention Type: DRUG

HDV-L will be used as the mealtime insulin

Lispro (LIS)

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

Group Type: ACTIVE_COMPARATOR

Lispro

Intervention Type: DRUG

Lispro will be used as the mealtime insulin

Interventions

HDV-Lispro

HDV-L will be used as the mealtime insulin

Intervention Type: DRUG

Lispro

Lispro will be used as the mealtime insulin

Intervention Type: DRUG

Other Intervention Names

HDV-L; LIS

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diasome Pharmaceuticlas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruth Weinstock, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

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

Countries

United States

Other Identifiers

DP 01-2023-01

Identifier Type: -

Identifier Source: org_study_id