21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus

What Was Tested

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

It had two arms (groups): one (experimental) and one (active comparator).

Hepatic Directed Vesicle (HDV) is the active excipient, added to insulin lispro. HDV binds to a portion of the insulin lispro.

Sterile Water for Injection (SWFI) is added to the insulin lispro, to dilute the insulin lispro equal to the HDV insulin lispro.

The registry classes the interventions as drug.

More on the Plan

The study will consist of three periods.

Total duration will be approximately nine weeks, including a screening period of up to 14 days, a 7-day run-in period and two 21-day treatment periods.

Subjects will be screened and then they will undergo a week of baseline CGM.

They will then be randomized to one of two treatment sequences: three weeks of treatment with HDV-lispro followed by three weeks of treatment with insulin lispro diluted with sterile water to match the insulin concentration in HDV-lispro, or the same treatments in the reverse order.

Who Took Part

Enrollment: 24 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 (a single re-test is allowable). Treatment with rapid analog insulin by CSII for the previous 6 months. Willingness to use insulin lispro as the analog insulin during the study period. Use of MiniMed Paradigm® pump for the previous 6 months. Pumps that employ low glucose suspend technology will NOT be allowed during the study.

The full record lists 8 inclusion and 6 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.).

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

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

Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.

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 2017-05-18 with completion listed for 2018-01-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glucose area under the curve (time frame: 21 days).

It also tracked 1 secondary outcome, for example total units Insulin.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 24 people.

Its size is small, so on its own it can only give an early look.

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.