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

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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.

Targeted Conditions

Study Overview

Start Date
January 23, 2024
Completion Date
March 1, 2026
Enrollment
230
Date Posted
February 2, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

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

Eligibility

Minimum Age (years)
18
Maximum Age (years)
79
Eligibility Criteria
Inclusion 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

Exclusion Criteria:

known or specific allergy to any component of the study drug, the active comparator
pregnant or breast-feeding, or intends 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 90 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.

Study Contact Info

Study Contact Name
Todd Hobbs, MD; Caroline ElSanadi, PhD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT06238778