ACTIVE_NOT_RECRUITING

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

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Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus Type 1CGMRandomizedHDVLispro

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-23
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06238778

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.

Ages Eligible for Study:18 Years to 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * clinical diagnosis Type 1 diabetes with C-peptide \<=0.6 ng/mL and using insulin for at least 6 months
  2. * willing to use study provided insulin as the only bolus insulin and insulin degludec as the basal insulin
  3. * willing to use CGM device throughout the study
  4. * screening A1C \>= 6.5% and \<= 10.0% daily insulin dose \<= 1.25 U/kg/day
  1. * known or specific allergy to any component of the study drug, the active comparator
  2. * pregnant or breast-feeding, or plans to become pregnant at any time during duration of study
  3. * current use of hydroxyurea
  4. * 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
  5. * received any investigational drug within prior 30 days
  6. * Clinically significant abnormalities on screening laboratory testing including liver enzymes
  7. * 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)
  8. * employed by or having immediate family members employed by the sponsor or directly involved in conducting the clinical trial.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Marvel Clinical Research
Huntington Beach, California, 92647
United States
Pasadena Clinical Trials
Pasadena, California, 91101
United States
Diabetes Research Center
Tustin, California, 92780
United States
University of Colorado, Barbara Davis Center
Denver, Colorado, 80045
United States
East Coast Institute for Research
Jacksonville, Florida, 32216
United States
University of Miami Diabetes Research Institute
Miami, Florida, 33136
United States
Metabolic Research Institute
West Palm Beach, Florida, 33401
United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
United States
East Coast Institute for Research
Canton, Georgia, 30114
United States
Physicians Research Associates, LLC
Lawrenceville, Georgia, 30046
United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
United States
University of Chicago Kovler Diabetes Center
Chicago, Illinois, 60637
United States
Endeavor Health
Skokie, Illinois, 60077
United States
Indiana Medical Research Institute
Merrillville, Indiana, 46410
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Asheville Clinical Research
Asheville, North Carolina, 28803
United States
UNC EnDO Clinical Research Unit
Chapel Hill, North Carolina, 27514
United States
Physician's East
Greenville, North Carolina, 27834
United States
University Hospitals Medical Center
Cleveland, Ohio, 44106
United States
Texas Diabetes & Endocrinology
Austin, Texas, 78749
United States
Tekton Research, LLC
Irving, Texas, 75039
United States
Tekton Research, LLC
McKinney, Texas, 75069
United States
Texas Diabetes % Endocrinology
Round Rock, Texas, 78681
United States
Clinical Trials of Texas
San Antonio, Texas, 78229
United States
Tekton Research, LLC
San Antonio, Texas, 78251
United States
Wasatch Clinical Research, LLC 310
Salt Lake City, Utah, 84107
United States
Virginia Endocrinology Research
Chesapeake, Virginia, 23321
United States

Collaborators and Investigators

Sponsor: Diasome Pharmaceuticlas, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-23
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-01-23
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Diabetes Mellitus Type 1
  • CGM
  • Randomized
  • HDV
  • Lispro

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 1