A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SAR438544 in Comparison to Glucagon in Type 1 Diabetes Mellitus Patients Under Induced Hypoglycemia

What Was Tested

The trial (phase 1) is built around Insulin (regular human) and Glucagon.

It had three arms (groups): one (experimental), Glucagon (active comparator) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

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

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

Examples of who could join: Male or female patients, between 18 and 60 years of age, inclusive, with T1DM for at least one year, as defined by the American Diabetes Association (ADA). Body weight between 50.0 and 110 kg, inclusive, the body mass index (BMI) between 18.5 and 30.0 kg/m\^2, inclusive. Stable insulin regimen for at least 2 months prior to study and self-monitoring of blood glucose before screening visit. Having given written informed consent prior to undertaking any study-related procedure. Not under any administrative or legal supervision.

The full record lists 13 inclusion and 16 exclusion criteria; among the exclusions: severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit; frequent severe 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

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

It started in 2016-04 with completion listed for 2016-11.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Time to reach a smoothed blood glucose of [amount hidden]/dL after initial administration of investigational medicinal product.

It also tracked 13 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 Insulin (regular human) and Glucagon in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Glucagon compound page, all human trials.