A Study to Compare Pharmacokinetics (PK) and Pharmacodynamics (PD) of SAR341402 to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

Primary Objective: To compare exposure and activity of SAR341402 to NovoRapid® and NovoLog®.

Secondary Objective: To assess the safety and tolerability of SAR341402.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 30 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: Male or female subjects with diabetes mellitus type 1 for more than one year. 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 6 inclusion and 8 exclusion criteria; among the exclusions: more than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months; 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.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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

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 2012-11-14 with completion listed for 2012-12-28.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Assessment of PK parameters: maximum plasma concentration (Cmax) (time frame: 12 hours). Assessment of PK parameters: Area under the concentration versus time curve (AUC) (time frame: 12 hours). Assessment of PD parameters: Area under the body weight standardized glucose infusion rate (GIR) (time frame: 12 hours).

It also tracked 9 secondary outcomes, for example Assessment of PK: Fractional area under the concentration versus time curve, Assessment of PK: time to reach INS-Cmax (INS-tmax), Assessment of PK: time to reach INS-t1/2z (INS-t1/2z), Assessment of PD: Fractional area under the body weight standardized GIR versus time curve, Assessment of PD: Maximum smoothed body weight standardized GIR (GIRmax) and Assessment of PD: Time to GIRmax (GIR-tmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 30 people.

Its size is small, so on its own it can only give an early look.

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.