A Research Study of How Faster-acting Insulin Aspart Moves Into, Through, and Out of the Body and How it Works in the Body When Given Through an Insulin Pump to People With Type 1 Diabetes

What Was Tested

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

The participants will be in the study for approx. 21 days.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 58 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 aged 18 - 64 years (both inclusive) at the time of signing informed consent. Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer. Body mass index 18.5 - 28.0 kg/sqm (both inclusive). Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer.

The full record lists 4 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.

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

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

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

It started in 2017-07-03 with completion listed for 2017-11-20.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to 30 min.

It also tracked 24 secondary outcomes, for example Continuous subcutaneous infusion related time from bolus to max insulin aspart concentration, Continuous subcutaneous infusion related time from bolus to max baseline corrected insulin aspart concentration, Continuous subcutaneous infusion related time from bolus administration to max of baseline corrected Glucose Infusion Rate, Area under the glucose infusion rate curve based on concentrations from -2 to 0 hours, Area under the glucose infusion rate curve based on concentrations from 12 to 14 hours and Continuous subcutaneous infusion related max of baseline corrected Glucose Infusion Rate.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 58 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.