Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes

What Was Tested

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

It had three arms (groups): BIOD-238 (experimental), BIOD-250 (experimental) and Humalog (active comparator).

Subcutaneous injection.

Subcutaneous injection.

Subcutaneous injection.

The registry classes the interventions as drug.

More on the Plan

The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®.

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 70 years.

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

Examples of who could join: Age: ≥18 to ≤70 years. Body Mass Index: ≥18 and ≤35 kg/m2. Diagnosed with Type 1 Diabetes Mellitus for at least 1 year.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: type 2 diabetes mellitus; serum c-peptide \>1.0 ng/ml; history of hypersensitivity to any of the components in the study medication.

How the Study Was Run

Design: randomized, crossover and double-blind.

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

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

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 and investigator.

It started in 2012-08 with completion listed for 2012-12.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to 1/2 maximal insulin concentration (time frame: 480 minutes).

It also tracked 4 secondary outcomes, for example Time to maximal insulin concentration, Time to 1/2 maximal insulin concentration after peak, Visual analog scale and AUC 0-30 and AUC 0-60.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of 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 Lispro compound page, all human trials.