A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

This trial is conducted in Europe.

It had two arms (groups): FIAsp followed by NovoRapid® (experimental) and NovoRapid® followed by FIAsp (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 48 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 at least 12 months. Body mass index (BMI) 18.5-28.0 kg/m\^2 (both inclusive). Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months.

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

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

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.

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2013-11 with completion listed for 2014-03.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve (time frame: From 0 to 30 minutes).

It also tracked 2 secondary outcomes, for example CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve and CSII bolus related baseline corrected area under the glucose infusion rate curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 48 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.