A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM

What Was Tested

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

This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.

Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.

It had three arms (groups): HinsBet® (experimental), Humalog® (active comparator) and Huminsulin® Normal (active comparator).

The registry classes the interventions as drug.

Who Took Part

36 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male or female subject aged 18-64 years (both inclusive). Type 1 diabetes mellitus (as diagnosed clinically) \>= 12 months. Treated with multiple daily insulin injections or CSII \>= 12 months. BMI 18.5-28.0 kg/m\^2 (both inclusive).

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: known or suspected hypersensitivity to imps or related products; type 2 diabetes mellitus; previous participation in this trial. participation is defined as randomised.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

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.

Each person switched between Insulin Lispro 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 Insulin Lispro.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2016-04 with completion listed for 2016-08.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: BG1h (time frame: 1 hour).

It also tracked 6 secondary outcomes, for example ΔBG1h, AUCBG,0-1h, ΔAUCBG,0-1h, AUCIns,0-1h, Adverse Events and Local tolerability (Number of injection site reactions).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin Lispro in 36 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.