Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration

What Was Tested

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

The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.

It had three arms (groups): BIOD-123 (experimental), BIOD-125 (experimental) and Humalog (active comparator).

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 70 years.

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

Examples of who could join: Age: ≥18 - ≤70 years. BMI: ≥18 - ≤30 kg/m2. Diagnosed with type 1 diabetes mellitus for at least 1 year. Insulin antibody ≤10 μU/mL at screening.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: type 2 diabetes mellitus; history of \>2 severe hypoglycemic events within the 3 months prior to screening; serum c-peptide \>1.0 ng/ml.

How the Study Was Run

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

Because people in this Insulin Lispro 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 participants took both Insulin Lispro and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Lispro.

Those kept unaware of assignments: participant and investigator.

It started in 2012-02 with completion listed for 2012-03.

Its stated primary purpose is treatment.

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.