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

Diabetes Mellitus, Type 1 Clinical Trial

— OPTI-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238778
• Other study ID #: DP 01-2023-01
• Status: Recruiting
• Phase: Phase 2
• Start date: January 23, 2024
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: Diasome Pharmaceuticlas, Inc.
• Contact: Todd Hobbs, MD
• Phone: 216-780-9324
• Email: thobbs[@]diasome.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: March 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• HDV-Lispro
HDV-L will be used as the mealtime insulin
• Lispro
Lispro will be used as the mealtime insulin

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Texas Diabetes & Endocrinology	Austin	Texas
United States	Texas Diabetes % Endocrinology	Round Rock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Diasome Pharmaceuticlas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypoglycemia events	CGM-measured rates of nocturnal level 2 hypoglycemia events	during the first 6 weeks of the maintenance period
Primary	hypoglycemia percentage of time	CGM-measured nocturnal percent time	during the first 6 weeks of maintenance period
Secondary	blood chemistry values	Triglyceride levels, Liver enzymes	baseline through study completion, an average of 7 months