Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 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): Treatment period 1 (experimental) and Treatment period 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 26 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 1 diabetes for at least 12 months. BMI (body mass index) below 35 kg/m\^2. Able and willing to perform self-blood glucose monitoring (SBGM).

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: treatment with insulin aspart within the last 14 days prior to this trial; the receipt of any investigational drug within the last 30 days prior to this trial; A history of drug abuse or alcohol dependence within the last 5 years.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Because people in this Insulin Aspart 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 Aspart and the comparison at some point, usually with a gap in between.

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 and investigator.

It started in 2001-01 with completion listed for 2001-06.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the serum insulin curve 6-14 hours after dinner at day 15.

It also tracked 8 secondary outcomes, for example Area under the serum insulin curve 6-14 hours after dinner at day 1, Area under the serum insulin curve 0-6 hours after dinner, Area under the curve 0-24 hours, Serum insulin, Apparent t½ (apparent elimination half life) and Cmax, maximum concentration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 26 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 Aspart compound page, all human trials.