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Comparing a new liver-targeted insulin to standard insulin in adults with Type 1 diabetes

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

Phase 2 Interventional Diasome Pharmaceuticlas, Inc. · NCT06238778

This study is testing a new liver-targeted insulin to see if it can help adults with Type 1 diabetes have better blood sugar control and fewer nighttime lows compared to standard insulin.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment230 (estimated)
Ages18 Years to 79 Years
SexAll
SponsorDiasome Pharmaceuticlas, Inc. Industry-sponsored
Locations27 sites (Huntington Beach, California and 26 other locations)
Trial IDNCT06238778 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of Hepatocyte-Directed Vesicles-insulin lispro (HDV-L) compared to standard insulin lispro in adults with Type 1 diabetes who are also using insulin degludec. Participants will be randomly assigned to receive either the new liver-targeted insulin or the standard insulin while using continuous glucose monitoring to track their blood sugar levels. The study will last up to 32 weeks, including periods for screening, dose optimization, and maintenance. The primary goal is to determine if HDV-L can reduce nocturnal hypoglycemia while maintaining or improving overall glycemic control as measured by HbA1c levels.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with Type 1 diabetes who have been using insulin for at least six months and meet specific glycemic criteria.

Not a fit: Patients who are pregnant, breastfeeding, or have certain medical conditions or allergies to study drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of low blood sugar episodes in patients with Type 1 diabetes.

How similar studies have performed: While the concept of liver-targeted insulin is innovative, similar approaches have shown promise in preliminary studies, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Huntington Beach, California and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 1Diabetes Mellitus Type 1CGMRandomizedHDVLispro
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.