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

NCT06238778 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2025-08-19

No results posted yet for this 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

  • Diabetes Mellitus, Type 1

Interventions

DRUG

HDV-Lispro

HDV-L will be used as the mealtime insulin

DRUG

Lispro

Lispro will be used as the mealtime insulin

Sponsors & Collaborators

  • Diasome Pharmaceuticlas, Inc.

    lead INDUSTRY

Principal Investigators

  • Ruth Weinstock, MD · State University of New York - Upstate Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2025-10-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06238778 on ClinicalTrials.gov