Comparison of Exposure and Activity of SAR341402 Mix 70/30 to NovoLog Mix 70/30, NovoMix 30 and SAR341402 Rapid-acting Solution in Patients With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 1) is built around Insulin Aspart.

It had four arms (groups): Test (T) (experimental), Reference 1 (R1) (active comparator), Reference 2 (R2) (active comparator) and Reference 3 (R3) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 52 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Anti-insulin antibody titer ≤30.0 kU/L. Stable insulin regimen for at least 2 months prior to study. Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month); presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician; likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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.

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2017-12-13 with completion listed for 2018-03-22.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: (Cohort 1) Assessment of PK parameter: Maximum insulin concentration (INS-Cmax) (time frame: 24 hours). (Cohort 1) Assessment of PK parameter: Area under the insulin concentration time curve (INS-AUClast) (time frame: 0 to 24 hours). (Cohort 2) Assessment of PK parameters: Area under the insulin concentration time curve from 0 to 4 hours post administration (INS-AUC0-4H) (time frame: 0 to 4 hours).

It also tracked 12 secondary outcomes, for example Assessment of PK parameter: Area under the insulin concentration time curve from 0 to infinity (INS-AUC), Assessment of PK parameter: Time to INS-Cmax, Assessment of PK parameter: Half-life (t1/2), Assessment of PD parameter: GIR versus time curve from 0 to 24 hours post administration (GIR-AUC0-24H), Assessment of PD parameter: Maximum smoothed body weight standardized glucose infusion rate (GIRmax) and Assessment of PD parameter: Time to GIRmax (GIR-tmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 52 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.