Clinical trial NCT06238778: Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus Type 1
CGM
Randomized
HDV
Lispro
Lead sponsor: Diasome Pharmaceuticlas, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-02
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind interventional study
Primary purpose: TREATMENT

Brief 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.

Detailed description: Individuals age 18 up to 80 years with Type 1 diabetes using multiple daily injections of bolus insulin plus basal insulin will be enrolled into a double-blind randomized controlled trial to assess the efficacy, safety, and tolerability of Hepatocyte-Directed Vesicles-insulin lispro (HDV-L) versus lispro alone (LIS) used in combination with insulin degludec. The study includes (1), a screening period up to 3 weeks, (2), a Run-in Period of 2 weeks to assess eligibility and to transition to use of insulin lispro and insulin degludec and unmasked continuous glucose monitoring (CGM), )3), a 12-week dose optimization period to optimize bolus and basal insulin doses,, (4), a 13-week maintenance period, and (5), a 2 -week transition follow-up period.

The primary objective of the study is to determine if the addition of HDV to insulin lispro results in an improvement in glycemic control as defined by decreasing evidence of nocturnal hypoglycemia while maintaining or improving glycated hemoglobin (HbA1c). Other outcomes related to glycemic control will also be evaluated.

Eligibility 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.

Primary outcomes:
measure: hypoglycemia events
timeFrame: during the first 6 weeks of the maintenance period
measure: hypoglycemia percentage of time
timeFrame: during the first 6 weeks of maintenance period
Secondary outcomes:
measure: blood chemistry values
timeFrame: baseline through study completion, an average of 7 months
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Pasadena
country: United States
facility: Pasadena Clinical Trials
state: California
city: Tustin
country: United States
facility: Diabetes Research Center
state: California
city: Denver
country: United States
facility: University of Colorado, Barbara Davis Center
state: Colorado
city: Jacksonville
country: United States
facility: East Coast Institute for Research
state: Florida
city: Miami
country: United States
facility: University of Miami Diabetes Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Canton
country: United States
facility: East Coast Institute for Research
state: Georgia
city: Lawrenceville
country: United States
facility: Physicians Research Associates, LLC
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Kovler Diabetes Center
state: Illinois
city: Skokie
country: United States
facility: Endeavor Health
state: Illinois
city: Merrillville
country: United States
facility: Indiana Medical Research Institute
state: Indiana
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Asheville
country: United States
facility: Asheville Clinical Research
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC EnDO Clinical Research Unit
state: North Carolina
city: Greenville
country: United States
facility: Physician's East
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Medical Center
state: Ohio
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
city: Irving
country: United States
facility: Tekton Research, LLC
state: Texas
city: McKinney
country: United States
facility: Tekton Research, LLC
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes % Endocrinology
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: San Antonio
country: United States
facility: Tekton Research, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC 310
state: Utah
city: Chesapeake
country: United States
facility: Virginia Endocrinology Research
state: Virginia
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Ruth Weinstock, MD
role: PRINCIPAL_INVESTIGATOR
References: