A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Lispro.

It had two arms (groups): BIOD-123 (experimental) and Lispro (Humalog) (active comparator).

BIOD-123 used as prandial insulin.

Lispro (Humalog) used as prandial insulin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 132 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Established clinical diagnosis of type 1 diabetes, consistent with ADA classification criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year. Age: 18 years old, or older. Body Mass Index: between 18 and 35 kg/m2, inclusive. Willing to use insulin glargine as the only basal insulin throughout the duration of the trial. Willingness not to use insulin pump treatment and only use the study glucose meter and CGM devices during the duration of the trial.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: history of known hypersensitivity to any of the components in the study medication; treatment with pramlintide or glp-1 analogs within 30 days of screening or anticipated use of these medications during the course of the study; consistent recent hypoglycemic unawareness within the last six months.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin Lispro study did not mask who received what.

It started in 2012-08 with completion listed for 2013-06.

It ran at 34 sites in United States (34).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1C (time frame: Baseline and 18 week treatment period).

It also tracked 3 secondary outcomes, for example Hypoglycemic event rates and Daily blood glucose measures.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 132 people.

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.