Overview

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

Trial end date:
2026-01-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

University of California, San Diego

Collaborator:

The Leona M. and Harry B. Helmsley Charitable Trust

Treatments:

Insulin Lispro