Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

A smarter insulin that aims for the liver could curb dangerous nighttime dips

NCT ID NCT06238778

Disease control Sponsor: Diasome Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial tests whether a specially designed mealtime insulin, HDV-insulin lispro, can reduce nighttime low blood sugar (hypoglycemia) in adults with type 1 diabetes. Participants will use continuous glucose monitors and work with doctors to adjust doses. One group receives the liver-targeted insulin, while the other uses standard insulin lispro. The study lasts up to 32 weeks and also tracks blood fats and liver enzymes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HDV-Insulin lispro, a liver-targeted form of mealtime insulin
What this could lead to
If successful, this approach could reduce dangerous nighttime low blood sugar episodes in people with type 1 diabetes, improving safety and quality of life.
What could go wrong
This is an early-phase trial, so results may not hold up in larger studies. The liver-targeting insulin may not perform better than standard insulin and could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

227 people

The number who actually took part.

Started

Dec 2023

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diabetes mellitus, type 1 are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 1

Contacts and locations

Locations

  • Asheville Clinical Research

    Asheville, North Carolina, 28803, United States

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318, United States

  • Clinical Trials of Texas

    San Antonio, Texas, 78229, United States

  • Diabetes Research Center

    Tustin, California, 92780, United States

  • East Coast Institute for Research

    Jacksonville, Florida, 32216, United States

  • East Coast Institute for Research

    Canton, Georgia, 30114, United States

  • Endeavor Health

    Skokie, Illinois, 60077, United States

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076, United States

  • Indiana Medical Research Institute

    Merrillville, Indiana, 46410, United States

  • Marvel Clinical Research

    Huntington Beach, California, 92647, United States

  • Metabolic Research Institute

    West Palm Beach, Florida, 33401, United States

  • Pasadena Clinical Trials

    Pasadena, California, 91101, United States

  • Physician's East

    Greenville, North Carolina, 27834, United States

  • Physicians Research Associates, LLC

    Lawrenceville, Georgia, 30046, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Tekton Research, LLC

    Irving, Texas, 75039, United States

  • Tekton Research, LLC

    McKinney, Texas, 75069, United States

  • Tekton Research, LLC

    San Antonio, Texas, 78251, United States

  • Texas Diabetes % Endocrinology

    Round Rock, Texas, 78681, United States

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78749, United States

  • UNC EnDO Clinical Research Unit

    Chapel Hill, North Carolina, 27514, United States

  • University Hospitals Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Chicago Kovler Diabetes Center

    Chicago, Illinois, 60637, United States

  • University of Colorado, Barbara Davis Center

    Denver, Colorado, 80045, United States

  • University of Miami Diabetes Research Institute

    Miami, Florida, 33136, United States

  • Virginia Endocrinology Research

    Chesapeake, Virginia, 23321, United States

  • Wasatch Clinical Research, LLC 310

    Salt Lake City, Utah, 84107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.