Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes

What Was Tested

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

The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.

It had three arms (groups): Humalog® (active comparator), BIOD- 105 (experimental) and BIOD-107 (experimental).

Humalog®, administered subcutaneously on 1 occasion.

BIOD- 105 administered subcutaneously on 1 occasion.

BIOD-107 administered subcutaneously on 1 occasion.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 13 actual participants took part.

It was open to people of any sex aged from 19 years up to 70 years.

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

Examples of who could join: Body Mass Index: ≥ 18 - ≤ 28 kg/m2. Diagnosed with type 1 diabetes mellitus for at least 1 year. Insulin antibody less than or equal to 10 μU/mL at screening.

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

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Each person switched between Insulin (regular human) 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 (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2011-03 with completion listed for 2011-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Speed of absorption (time frame: 480 minutes).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Insulin Lispro in 13 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.