A Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 1, phase 2) is built around Insulin Lispro.

It had three arms (groups): Formulation A (experimental), Formulation B (experimental) and Formulation C (experimental).

VIAject®25 for subcutaneous application.

VIAject®7 for subcutaneous application.

Insulin Lispro for subcutaneous application.

The registry classes the interventions as drug.

Who Took Part

The registry lists 43 actual participants took part.

It was open to people of any sex aged from 19 years up to 65 years.

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

Examples of who could join: Age: ≥19 to ≤65 years. 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. Non-smoker, defined as no nicotine consumption for at least one year.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: type 2 diabetes mellitus; C-peptide value of \>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.

The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.

Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.

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 2009-07 with completion listed for 2009-09.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Serum insulin concentration (time frame: 0-480 minutes).

It also tracked 2 secondary outcomes, for example Serum insulin concentration and Glucose infusion rate.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin Lispro in 43 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.