Comparison of FiAsp and Aspart During Postprandial Exercise in Adults With Type 1 Diabetes

What Was Tested

The trial (phase 4) is built around Insulin Aspart.

Hypoglycemia is the main barrier for physical activity practice of patients with type 1 diabetes (T1D).

It had four arms (groups): Aspart - 60-minutes postprandial exercise (active comparator), Aspart - 120-minutes postprandial exercise (active comparator), FiAsp - 60-minutes postprandial exercise (active comparator) and FiAsp - 120-minutes postprandial exercise (active comparator).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 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: Males and females ≥ 18 years of old. Clinical diagnosis of type 1 diabetes for at least one year. Patients using multiple daily injections with basal-bolus insulin regimen and insulin analogs (pre-meal: Aspart, Lispro, Guilisine or Fiasp; basal: Detemir, Glargine U100 \& U300, Degludec U100). Written informed consent given.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery; ongoing pregnancy or breastfeeding; severe hypoglycemic episode within two weeks of screening.

How the Study Was Run

Design: 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.

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

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 2019-04-12 with completion listed for 2022-12-31.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 24 secondary outcomes, for example Decremental area under the curve of plasma glucose levels, Number of patients requiring an oral treatment for hypoglycemia, Total number of hypoglycemia episodes requiring treatment, Mean time (minutes) to the first hypoglycemic event, Amount of carbohydrates needed to treat a hypoglycemic event and Change in oxyhemoglobin in the vastus lateralis.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 40 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.