Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus

What Was Tested

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

It had 1 arm (groups): SAR439065 + insulin lispro (experimental).

The registry classes the interventions as drug.

More on the Plan

The total study duration for one patient is approximately 6.7 to 22.7 weeks (minimum to maximum duration, excluding screening).

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 patients, between 18 and 65 years of age, inclusive, with diabetes mellitus type 1 for more than one year, as defined by the American Diabetes Association. Body weight between 50.0 and 95 kg, inclusive, body mass index between 18.5 and 29 kg/m², inclusive. Stable insulin regimen for at least 2 months prior to study (with respect to safety of the patient and scientific integrity of the study). Having given written informed consent prior to undertaking any study-related procedure.

The full record lists 10 inclusion and 12 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

Design: randomized, crossover and open-label.

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

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

Being open-label, the Insulin Lispro study did not mask who received what.

It started in 2015-06 with completion listed for 2015-09.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Assessment of PD parameter: Area under the glucose infusion rate curve within 24 hours after administration of the investigational medicinal product or until administration of rescue insulin (GIR-AUC0-end) (time frame: 24 hours).

It also tracked 8 secondary outcomes, for example Assessment of PD parameters: Maximum smoothed glucose infusion rate (GIRmax), Assessment of PD parameters: Time to GIRmax (GIR-Tmax), Duration of blood glucose control (time to elevation of smoothed blood glucose profile above different prespecified clamp levels), Assessment of PK parameters: Baseline-corrected maximum serum concentration (INS-Cmax), Assessment of PK parameters: Time to INS-Cmax (INS-Tmax) and Assessment of PK parameters: Area under the concentration-time curve (INS-AUClast).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro 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 Lispro compound page, all human trials.