A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® 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 the United States of America (USA).

The aim of the trial is to evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects with type 1 diabetes.

It had three arms (groups): Formulation 1 (experimental), Formulation 2 (experimental) and Insulin aspart (NovoLog®) (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 43 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 mellitus (diagnosed clinically) for at least 12 months prior to the screening visit (Visit 1). Treatment with the same insulin analogue by CSII (continuous subcutaneous insulin infusion) for the previous 3 months prior to the screening visit (Visit 1). Using a MiniMed Paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months prior to the screening visit (Visit 1). Body Mass Index (BMI) below or equal to 35.0 kg/m\^2.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: history of diabetic ketoacidsosis (dka) episodes requiring hospitalization within 6 months prior to the screening visit (visit 1); history of abscess at the infusion site within 6 months prior to the screening visit (visit 1).

How the Study Was Run

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

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.

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 2012-09 with completion listed for 2013-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean change in plasma glucose concentration.

It also tracked 6 secondary outcomes, for example Self-measured plasma glucose (SMPG) 7-point profile, Self-measured plasma glucose (SMPG) 9-point profile, Number of adverse events (AEs) (including infusion site reactions/infections), Number of hypoglycaemic episodes, Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG) and Number of episodes of infusion set occlusions.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 43 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.