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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Condition
Diabetes Mellitus, Type 1
Intervention / Treatment

-

Contacts and Locations

Huntington Beach

Marvel Clinical Research, Huntington Beach, California, United States, 92647

Pasadena

Pasadena Clinical Trials, Pasadena, California, United States, 91101

Denver

University of Colorado, Barbara Davis Center, Denver, Colorado, United States, 80045

Miami

University of Miami Diabetes Research Institute, Miami, Florida, United States, 33136

West Palm Beach

Metabolic Research Institute, West Palm Beach, Florida, United States, 33401

Atlanta

Atlanta Diabetes Associates, Atlanta, Georgia, United States, 30318

Roswell

Endocrine Research Solutions, Inc., Roswell, Georgia, United States, 30076

Skokie

Endeavor Health, Skokie, Illinois, United States, 60077

Merrillville

Indiana Medical Research Institute, Merrillville, Indiana, United States, 46410

Syracuse

SUNY Upstate Medical University, Syracuse, New York, United States, 13210

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * clinical diagnosis Type 1 diabetes with C-peptide \<0.6 nmol/L 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 \<= 9.0% daily insulin dose \<= 1.25 U/kg/day
  • * 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, 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.

Ages Eligible for Study

18 Years to 79 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Diasome Pharmaceuticlas, Inc.,

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

Study Record Dates

2025-12