Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes

What Was Tested

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

This trial is conducted in the United States of America (USA).

The aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in subjects with type 1 diabetes.

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Subjects with type 1 diabetes treated with insulin for at least 12 months. BMI (Body Mass Index) between 18.0-29.0 kg/m\^2. Negative fasting C-peptide (below or equal to 0.6 ng/mL). Subject should be in good health based on medical history, physical examination and routine laboratory data.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: any known/suspected allergies to trial medication or similar products/devices; A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator; recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the investigator.

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.

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

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 2008-06 with completion listed for 2008-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the insulin aspart bolus concentration-time curve. Maximum plasma concentration (Cmax) of insulin aspart.

It also tracked 2 secondary outcomes, for example Time to maximum concentration (Tmax) of insulin aspart and AUC (area under the curve) of insulin aspart.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 24 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.