FIasp® vs. Novolog® in Type 1 Diabetics Using [amount hidden] Medtronic Pump

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

It had two arms (groups): Fiasp/Novolog (experimental) and Novolog/Fiasp (experimental).

The registry classes the interventions as device and drug.

More on the Plan

The investigator's hypothesis is that post prandial glucoses will be lower and time in range will be greater during the Fiasp® treatment period.

Subjects will have a 2 week screening period, 14 week treatment period and 30 Day follow up period.

After at least 7 weeks on treatment period one they will crossover to treatment period two on the opposite treatment for 7 additional weeks.

Who Took Part

40 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: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female, age ≥18 years at the time of signing informed consent. Documented diagnoses of T1DM ≥1 year prior to the day of screening. Ability and willingness to use the same insulin infusion sets throughout the trial. Using the same insulin for at least 30 days prior to screening.

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial products or related products; participation in another clinical trial within 28 days before the screening visit. note: clinical trials do not include non-interventional studies; subjects classified as being in new york heart association (nyha) class iv at screening.

How the Study Was Run

Design: randomized, crossover and open-label.

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

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2019-06-11 with completion listed for 2020-03-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 1-Hour Change in Postprandial Plasma Glucose (PPG) (time frame: 6th week of therapy).

It also tracked 19 secondary outcomes, for example 2-Hour Change in Postprandial Plasma Glucose (PPG), 1,5 Anhydroglucitol Levels, Fructosamine Levels, HbA1c, Insulin Use - Bolus and Insulin Use - Basal.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 40 people.

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.