Safety and Efficacy of BC LisPram

What Was Tested

The trial (phase 1) is built around Insulin Lispro.

It had three arms (groups): Rapid Insulin lispro - Conventional bolus (active comparator), BC LisPram - Conventional bolus (experimental) and BC LisPram - Dual wave bolus (experimental).

Participants will use subcutaneously-delivered rapid insulin (lispro) through pump therapy.

Participants will use subcutaneously-delivered BC LisPram through pump therapy.

The registry classes the interventions as drug.

More on the Plan

Subjects will be randomized to intervention sequences.

The first 6 participants will be randomly allocated to a sequence of three treatments composed of (i) treatment with active comparator insulin lispro, (ii) treatment with BC LisPram, and (iii) treatment with BC LisPram (dual wave bolus).

The following 10 participants will be randomly allocated to a sequence of either two or three treatments.

Each treatment period will last 50 hours.

Who Took Part

Enrollment: 16 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: current or ≤ 1 month use of other antihyperglycemic agents (sglt2, glp-1, metformin, acarbose, etc....); current use of glucocorticoid medication; use of medication that alters gastrointestinal motility.

How the Study Was Run

The set-up was randomized, crossover and open-label.

The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

Being open-label, the Insulin Lispro study did not mask who received what.

It started in 2021-07-28 with completion listed for 2022-06.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hypoglycaemic episodes (time frame: 0 to 50 hours). Gastrointestinal symptoms (time frame: 0 to 50 hours). Local tolerability at pump injection site (time frame: 0 to 50 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 16 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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