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

August 18, 2025 updated by: Diasome Pharmaceuticlas, Inc.

A Phase 2b Randomized, Double-blind Trial Comparing HDV-Insulin Lispro Versus Insulin Lispro Alone in Adults With Type 1 Diabetes Receiving Insulin Degludec

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Huntington Beach, California, United States, 92647
        • Marvel Clinical Research
      • Pasadena, California, United States, 91101
        • Pasadena Clinical Trials
      • Tustin, California, United States, 92780
        • Diabetes Research Center
    • Colorado
      • Denver, Colorado, United States, 80045
        • University Of Colorado, Barbara Davis Center
    • Florida
      • Jacksonville, Florida, United States, 32216
        • East Coast Institute for Research
      • Miami, Florida, United States, 33136
        • University of Miami Diabetes Research Institute
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Atlanta Diabetes Associates
      • Canton, Georgia, United States, 30114
        • East Coast Institute for Research
      • Lawrenceville, Georgia, United States, 30046
        • Physicians Research Associates, LLC
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Kovler Diabetes Center
      • Skokie, Illinois, United States, 60077
        • Endeavor Health
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Indiana Medical Research Institute
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Clinical Research
      • Chapel Hill, North Carolina, United States, 27514
        • UNC EnDO Clinical Research Unit
      • Greenville, North Carolina, United States, 27834
        • Physician's East
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Medical Center
    • Texas
      • Austin, Texas, United States, 78749
        • Texas Diabetes & Endocrinology
      • Irving, Texas, United States, 75039
        • Tekton Research, LLC
      • McKinney, Texas, United States, 75069
        • Tekton Research, LLC
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes % Endocrinology
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
      • San Antonio, Texas, United States, 78251
        • Tekton Research, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research, LLC 310
    • Virginia
      • Chesapeake, Virginia, United States, 23321
        • Virginia Endocrinology Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HDV Lispro (HDV-L)
Subjects in this arm will use degludec as their daily basal insulin, and HDV-lispro as their bolus insulin
Drug: HDV-Lispro
HDV-L will be used as the mealtime insulin
Other Names:
  • HDV-L
Active Comparator: Lispro (LIS)
Subjects in this arm will use degludec as their daily basal insulin and lispro as their bolus insulin
Drug: Lispro
Lispro will be used as the mealtime insulin
Other Names:
  • LIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypoglycemia events
Time Frame: during the first 6 weeks of the maintenance period
CGM-measured rates of nocturnal level 2 hypoglycemia events
during the first 6 weeks of the maintenance period
hypoglycemia percentage of time
Time Frame: during the first 6 weeks of maintenance period
CGM-measured nocturnal percent time
during the first 6 weeks of maintenance period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood chemistry values
Time Frame: baseline through study completion, an average of 7 months
Triglyceride levels, Liver enzymes
baseline through study completion, an average of 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diasome Pharmaceuticlas, Inc.

Investigators

  • Principal Investigator: Ruth Weinstock, MD, State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP 01-2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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