Mylan Insulin Aspart Study

What Was Tested

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

The registry classes the interventions as drug.

More on the Plan

After up to 3-week screening period, all subjects will be titrated on NovoLog® during a 4-week run-in period, and will be shifted from their current basal insulin to study insulin Lantus®.

After run-in period, subjects will be randomized; one group will receive MYL-1601D, while the other group will receive NovoLog® for 24 weeks.

Who Took Part

Enrollment: 478 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Written and signed informed consent. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening. Subject is able and willing to comply with the requirements of the study protocol.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: history or presence of a medical condition or disease that in the investigator's opinion would place the subject at an unacceptable risk from study participation; any elective surgery requiring hospitalization planned during the study period; subjects with major depressive illness in the last 3 years.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

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

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

It started in 2018-11-07 with completion listed for 2019-12-28.

It ran at 158 sites in United States (158).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Treatment Emergent Antibody Response (TEAR) (time frame: Baseline to week 24).

It also tracked 6 secondary outcomes, for example Change in HbA1c From Baseline, Change in Fasting Plasma Glucose From Baseline and Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 478 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.