BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Insulin (regular human) and Insulin Lispro for insulin resistance, prediabetes & type 2 diabetes.

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

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: history of bariatric surgery; corticosteroid therapy; females who are breast feeding or pregnant.

How the Study Was Run

Design: randomized, crossover and single-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the insulin resistance, prediabetes & type 2 diabetes participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Only one side, usually the insulin resistance, prediabetes & type 2 diabetes 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 2014-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Post-breakfast glucose exposure (AUC) (time frame: 0-330 minutes).

It also tracked 5 secondary outcomes, for example Insulin exposure (AUC), Maximal insulin concentration, Post-lunch and post-dinner glucose exposures (AUC) and Injection site toleration (VAS and severity scales).

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 with insulin resistance, prediabetes & type 2 diabetes.

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, Insulin resistance, prediabetes & type 2 diabetes research.