Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Insulin (regular human) and Insulin Lispro.

It had four arms (groups): BIOD-531 pre-meal (experimental), Humalog Mix 75/25 pre-meal (active comparator), Humulin R U-500 (active comparator) and BIOD-531 post-meal (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 12 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: BMI \> 25 kg/m2. Type 2 Diabetes Mellitus.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: type 1 diabetes mellitus; history of bariatric surgery; corticosteroid therapy.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.

Those kept unaware of assignments: participant.

It started in 2014-05 with completion listed for 2014-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Post-standardized meal glucose exposure (AUC) (time frame: 0-120 minutes after meal).

It also tracked 7 secondary outcomes, for example Insulin exposure (AUC), Maximal insulin concentration, Post breakfast and post-lunch glucose exposure (AUC), Post-breakfast and post-lunch maximal glucose concentrations, Injection site toleration (VAS and severity scales) and Draize injection site erythema and edema scoring.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin (regular human) and Insulin Lispro in 12 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 (regular human) compound page and the Insulin Lispro compound page, all human trials.