A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of SAR438544 in Comparison to Placebo and Glucagon in Healthy Subjects and Type 1 Diabetes Mellitus Patients

What Was Tested

The trial (phase 1) is built around Glucagon.

It had six arms (groups): one (experimental), one (experimental), one (experimental), Placebo (placebo comparator) and Glucagon (active comparator).

The registry classes the interventions as drug.

More on the Plan

Healthy subjects: The total duration of study per subject is up to 4.5 weeks with 2 to 21 days screening period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration.

T1DM patients: The total duration of study per patient is up to 5.5 weeks with 3 to 28 days screening period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration.

One or more interim analyses may be performed to support decisions for the next steps of the study.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female subjects, between 18 and 45 years of age, inclusive. Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). Having given written informed consent prior to undertaking any study-related procedure. Not under any administrative or legal supervision.

The full record lists 24 inclusion and 29 exclusion criteria; among the exclusions: frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month); blood donation, any volume, within 2 months before inclusion; smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

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

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

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2015-12 with completion listed for 2016-02.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Number of patients with adverse events (time frame: Day 1 to Day 7 (+/- 1 day)).

It also tracked 11 secondary outcomes, for example Assessment of PD parameter: BG-maximum concentration (BG-Cmax), Assessment of PD parameter: BG-time to Cmax (BG-tmax), Assessment of PK parameter (recombinant glucagon and SAR438544): Cmax, Assessment of PK parameter (recombinant glucagon and SAR438544): tmax, Assessment of PK parameter (recombinant glucagon and SAR438544): tlast and Assessment of PK parameter (recombinant glucagon and SAR438544): terminal half life.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 20 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 Glucagon compound page, all human trials.