Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes

What Was Tested

In this phase 1 trial, researchers set out to test 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

27 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. Currently on basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily. BMI (Body Mass Index) maximum 35 kg/m\^2. Able and willing to perform self-blood glucose monitoring.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: the receipt of any investigational drug within the last 30 days prior to this trial; currently being treated with insulin aspart products; A history of drug abuse or alcohol dependence within the last 5 years.

How the Study Was Run

Design: randomized, crossover and double-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.

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 2001-05 with completion listed for 2001-07.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Steady state area under the glucose infusion rate profile, 6-12 hours.

It also tracked 9 secondary outcomes, for example GIRmax, the maximal glucose infusion rate value, tmax, time to maximum glucose infusion rate value, area under the glucose infusion rate profile, Cmax, maximum concentration, tmax, time to reach Cmax and Area under the curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 27 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.