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

What Was Tested

The trial (phase 2) is built around Insulin Lispro.

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.

It had two arms (groups): HDV Lispro (HDV-L) (experimental) and Lispro (LIS) (active comparator).

Subjects in this arm will use degludec as their daily basal insulin, and HDV-lispro as their bolus insulin.

Subjects in this arm will use degludec as their daily basal insulin and lispro as their bolus insulin.

The registry classes the interventions as drug.

More on the Plan

Other outcomes related to glycemic control will also be evaluated.

Who Took Part

Enrollment: 227 actual participants took part.

It was open to people of any sex aged from 18 years up to 79 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin Lispro and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Insulin Lispro, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-12-28 with completion listed for 2025-10-27.

It ran at 27 sites in United States (27).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: hypoglycemia events (time frame: during the first 6 weeks of the maintenance period). hypoglycemia percentage of time (time frame: during the first 6 weeks of maintenance period).

It also tracked 1 secondary outcome, for example blood chemistry values.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 227 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Lispro compound page, all human trials.