Feasibility Trial Testing the Bionic Pancreas With ZP4207

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Lispro and Glucagon.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as device and drug.

More on the Plan

This was a single-center, open-label, 2-part, randomized cross-over trial.

Part 2 of the trial using the iLet was consequently not conducted.

Subjects will also receive insulin lispro through the BP on both days.

Who Took Part

Enrollment: 13 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients with T1DM for at least 1 year, as defined by the American Diabetes Association. Age ≥ 18 years. Prescription medication regimen stable for \>1 month (except for medications not expected to affect trial safety or outcome, in the judgment of the investigator). Diabetes managed using an insulin pump for \>=6 months. Patients in good health according to age (medical history, physical examination, vital signs, 12-lead electrocardiograms \[ECGs\], laboratory assessments), as judged by the Investigator.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: previous exposure to zp4207 or adverse reaction to glucagon; history of liver disease or current abnormal liver function tests (lfts); renal failure.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Because people in this Insulin Lispro study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.

Everyone knew when Insulin Lispro was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-11 with completion listed for 2017-05-24.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters (time frame: Up to 50 days).

It also tracked 18 secondary outcomes, for example Pain Measured on a Visual Analog Scale (VAS), Nausea Measured on a Visual Analog Scale (VAS), Glycemic Regulation, Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured, CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM and CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro and Glucagon in 13 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Lispro compound page and the Glucagon compound page, all human trials.