Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro to Further Improve Glycemic Control

What Was Tested

This registered phase 2 trial tested Insulin Lispro.

It had two arms (groups): HDV insulin lispro 100 UNT/mL (experimental) and insulin lispro 100 UNT/ML (active comparator).

The registry classes the interventions as drug.

More on the Plan

Subjects will be screened and then monitored with one week of baseline CGM.

They will then be randomized to one of two treatment groups: (A) six weeks of treatment with HDV-lispro (B) six weeks of treatment with insulin lispro diluted with sterile water alone.

All subjects will use insulin glargine or insulin degludec for basal insulin coverage throughout the trial.

A test meal study (standardized liquid test meal) to be conducted at the beginning of treatment (baseline study) and at the end of the six week treatment period (treatment comparison study).

Who Took Part

The registry lists 46 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: T1DM ≥12 months. C-peptide \<0.6 ng/mL (single retest allowed). Treatment with rapid analog insulin for the previous 6 months and willing to use insulin vial and syringe to deliver rapid acting insulin during the study. Currently using either insulin glargine (U100 only) or insulin degludec for basal insulin therapy for at least 4 weeks prior to study. Not using insulin pump delivery systems during the previous 3 months.

The full record lists 10 inclusion and 15 exclusion criteria; among the exclusions: known or suspected allergy to any component of any of the study drugs in this trial; A patient who has unstable proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator; use of oral anti-diabetic or non-insulin anti-diabetic injection therapies (e.g. sglt-2 inhibitors, pramlintide, glp-1 agonists, etc.) during the 4 weeks prior to randomization.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

As a double-blind Insulin Lispro study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2017-04-18 with completion listed for 2017-11-15.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The amount of time, in minutes, glucose levels are within range ([amount hidden]/dL).

It also tracked 6 secondary outcomes, for example Postprandial glucose levels in mg/dL following test meal challenge, HbA1c levels in percentage (%) at beginning of trial compared to HbA1c levels at the end of the study and Self-Monitoring Blood Glucose (SMBG) results in mg/dL before and after every meal.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 46 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.