Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

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

NCT06238778 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG HDV-Lispro
  • DRUG Lispro

Study Locations (20)

Georgia

  • Atlanta Diabetes Associates — Atlanta
  • East Coast Institute for Research — Canton
  • Physicians Research Associates, LLC — Lawrenceville
  • Endocrine Research Solutions, Inc. — Roswell

California

  • Marvel Clinical Research — Huntington Beach
  • Pasadena Clinical Trials — Pasadena
  • Diabetes Research Center — Tustin

Florida

  • East Coast Institute for Research — Jacksonville
  • University of Miami Diabetes Research Institute — Miami
  • Metabolic Research Institute — West Palm Beach

North Carolina

  • Asheville Clinical Research — Asheville
  • UNC EnDO Clinical Research Unit — Chapel Hill
  • Physician's East — Greenville

Illinois

  • University of Chicago Kovler Diabetes Center — Chicago
  • Endeavor Health — Skokie

Colorado

  • University of Colorado, Barbara Davis Center — Denver

Indiana

  • Indiana Medical Research Institute — Merrillville

New York

  • SUNY Upstate Medical University — Syracuse

Trial Details

FieldValue
Enrollment Target 227 participants
Start Date 2024-01-23
Est. Completion 2025-12
Phase Phase 2

Sponsor

Diasome Pharmaceuticlas

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06238778

The ClinicalTrials.gov registry entry for NCT06238778 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 227 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Diasome Pharmaceuticlas, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions — of which HDV-Lispro is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06238778 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Georgia, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06238778 about?

NCT06238778 is a clinical study titled "Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro 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 f...

What is the current status of trial NCT06238778?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 227 participants. The study started on 2024-01-23. Estimated completion is 2025-12.

What conditions does trial NCT06238778 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06238778?

The interventions under investigation include: HDV-Lispro (DRUG), Lispro (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06238778?

This trial is sponsored by Diasome Pharmaceuticlas, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06238778 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial