Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin N and Huminsulin® Basal

What Was Tested

In this phase 1 trial, researchers set out to test NPH Insulin (isophane).

It had two arms (groups): one (experimental) and Huminsulin® Basal (active comparator).

The registry classes the interventions as drug.

More on the Plan

Daily injections of insulin are a necessity for many patients with diabetes mellitus in order to treat hyperglycemia.

Who Took Part

85 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject). Healthy male subject. Age between 18 and 55 years, both inclusive. Body Mass Index (BMI) between 18.5 and 28.0 kg/m\^2, both inclusive.

The full record lists 5 inclusion and 20 exclusion criteria; among the exclusions: known or suspected hypersensitivity to imps or related products; previous participation in this trial. participation is defined as randomised; receipt of any medicinal product in clinical development within 3 months before screening.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got NPH Insulin (isophane) and who got the comparison, which limits bias.

Each person switched between NPH Insulin (isophane) and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received NPH Insulin (isophane).

Those kept unaware of assignments: participant and investigator.

It started in 2016-11-16 with completion listed for 2017-01-20.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): PK: AUCins.0-24h, area under the serum insulin concentration curve from 0 to 24 hours (time frame: 24 hours). PK: Cins.max, maximum observed insulin concentration (time frame: 24 hours).

It also tracked 16 secondary outcomes, for example PK: AUCins.0-6h, AUCins.0-12, areas under the serum insulin concentration curve in the indicated time intervals, PK: AUCins.0-∞, area under the serum insulin concentration-time curve from 0 hours to infinity, PK: tmax, time to maximum observed serum insulin concentration, PK: t½, terminal serum elimination half-life calculated as t½=ln2/λz, PK: λz, terminal elimination rate constant of insulin and PD: AUCGIR.0h-last, area under the glucose infusion rate curve from 0 hours until the end of clamp.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of NPH Insulin (isophane) in 85 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NPH Insulin (isophane) compound page, all human trials.