NCT05689424

Suppression of Endogenous Glucose Production by Injectable HDV-Insulin Lispro: A Dose Response Study in Human Subjects With Type 1 Diabetes

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Single-center, double-blind, random-sequence study assessing the HDV dose-response relationship to Endogenous Glucose Production (EGP), Free Fatty Acids (FFA) and Glucose Disposal Rate (GDR) during a euglycemic clamp procedure following overnight stabilization of blood glucose with intravenous insulin (and, if needed intravenous glucose). EGP and GDR will be determined using established radioisotope methodology. The concentration of Hepatic Directed Vesicles (HDV) in the insulin lispro (LIS) infused during the clamp procedure will be varied such that the percentage of HDV-bound LIS will range from 0%, 1%, 10%, and 100%. Each participant will thus undergo four clamp procedures at the four different HDV levels. LIS will be infused at a constant dose (6 mU/m2/min) for each of the four procedures.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	HDV-Insulin Lispro	The name of the investigational drug is Hepatic Directed Vesicles + Insulin Lispro (HDV-bound LIS). It is a nano-carrier-based formulation of insulin which is the active therapeutic ingredient in the product. The nano-carrier component of the formulation contains a hepatic target molecule, biotin phosphatidylethanolamine, which has an affinity for hepatocytes and enables the product to deliver insulin directly to the liver.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2023-01-19
• Last updated: 2024-10-10

Regulatory

• FDA-regulated drug study