The Efficacy and Safety of Faster Insulin Aspart (Fiasp®) Compared to Conventional Insulin Aspart (NovoLog®) as Correction Bolus

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Aspart.

These endpoints will be determined by CGM (Dexcom) from data exported from the Dexcom Clarity program.

It had two arms (groups): No Intervention: Conventional Insulin Aspart (NovoLog®) (no intervention) and Faster Insulin Aspart (Fiasp®) (active comparator).

The registry classes the interventions as drug.

More on the Plan

Patients with type 1 DM using CSII require bolus insulin for two purposes: first, to cover carbohydrate intake to control postprandial glucose, and second, to correct episodes of hyperglycemia.

There is consequently an unmet need in insulin delivery, and in particular in CSII, for an insulin which can correct a hyperglycemic episode more rapidly than is currently possible with rapid-acting insulin analogues.

Only one of these systems, the Dexcom, reads continuously to the patient and has alarms to warn of impending episodes of hyper- or hypoglycemia, and this is the system used most commonly by patients with type 1 DM using open-loop CSII.

However, these guidelines were created for use with rapid acting insulin analogues.

Who Took Part

Enrollment: 45 planned participants were the target.

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 and female patients \> 18 years of age. Type 1 DM of \> 1 year duration. No episodes of severe hypoglycemia in the previous 3 months. Pump download shows regular meal bolusing, accurate carbohydrate counting ability, and willingness to use exercise markers in Dexcom. Females using adequate contraception.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: use of cgm other than dexcom g5 or g6 or a newer dexcom cgm version; females unwilling to use contraception, planning pregnancy or breastfeeding; use of any other glucose-lowering agents than insulin.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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

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

It started in 2019-03-27 with completion listed for 2021-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to stabilization of rising blood sugar by CGM after correction bolus (time frame: 2 weeks).

It also tracked 8 secondary outcomes, for example Incidence of early hypoglycemia, Change in Insulin Sensitivity Factor, Change in Insulin On Board, GlycoMark differences between arms, HbA1c differences between arms and Percent time spent in target range, hyperglycemic range, and hypoglycemic range.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 45 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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