A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes

What Was Tested

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

The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children \[6-11 years\], adolescents \[12-17 years\] and adults \[18-64 years\]) who have diabetes.

The blood sugar (glucose) lowering effect of faster aspart will also be investigated after consuming a meal replacement drink.

The effects of faster aspart will be compared to the effects of NovoRapid®.

It had two arms (groups): Faster aspart followed by insulin aspart (NovoRapid®) (experimental) and Insulin aspart (NovoRapid®) followed by faster aspart (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 46 actual participants took part.

It was open to people of any sex aged from 6 years up to 64 years.

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

Examples of who could join: Male or female aged 6-64 years (both inclusive) at the time of signing informed consent. Diagnosed with type 1 diabetes greater than or equal to 12 months prior to the day of screening. Body mass index for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults less than or equal to 28.0 kg/sqm.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily); not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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

Each person switched between Insulin Aspart 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 Aspart.

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

It started in 2018-01-08 with completion listed for 2018-07-05.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours (time frame: 0-12 hours).

It also tracked 24 secondary outcomes, for example AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes, AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes, AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour, AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour, AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours and Cmax,IAsp, maximum observed serum insulin aspart concentration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 46 people.

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

More context: the Insulin Aspart compound page, all human trials.