A Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Aspart.

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

The aim of this trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII) system in adult subjects with type 1 diabetes.

It had two arms (groups): FIAsp (experimental) and Insulin Aspart (active comparator).

The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period.

The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period.

The registry classes the interventions as drug.

Who Took Part

The registry lists 37 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: Male or female, age at least 18 years at the time of signing inform consent. Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months at the time of screening (Visit 1). Currently treated with insulin aspart, insulin lispro or insulin gluisine for at least 3 months prior to screening (Visit 1). Using an external CSII system for the previous 6 months prior to screening (Visit 1). Body Mass Index (BMI) 20.0-35.0 kg/m\^2.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: history of diabetic ketoacidosis (dka) episodes requiring hospitalization within 6 months prior to screening (visit 1); history of abscess at the infusion site within 6 months prior to screening (visit 1); hypoglycaemic unawareness as judged by the investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening (visit 1).

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2013-11-19 with completion listed for 2014-05-14.

It ran at 2 sites in United States (1) and Germany (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Microscopically Confirmed Episodes of Infusion Set Occlusions (time frame: During 6 weeks of treatment).

It also tracked 3 secondary outcomes, for example Number of Unexplained Episodes of Hyperglycaemia (Confirmed by Self-measured Plasma Glucose (SMPG)), Number of Episodes of Possible Infusion Set Occlusions and Number of Premature Infusion Set Changes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 37 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page, all human trials.