Acceleration of Insulin Action by Hyaluronidase During Closed-Loop Therapy

What Was Tested

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

"Closed loop artificial pancreas" systems have been under development for the control of blood sugars in those living with diabetes.

These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give.

The computer program then tells an insulin pump to deliver the insulin.

It had three arms (groups): ePID closed loop system without hyaluronidase (active comparator), ePID closed loop system with hyaluronidase at infusion site (experimental) and ePID closed loop system with hyaluronidase co-formulation (experimental).

Hyaluronidase will not be given while subject uses ePID closed loop system.

Hyaluronidase will be injected at insulin pump infusion site prior to the time that subject uses ePID closed loop system.

Hyaluronidase-insulin co-formulation will be used in study pump while subject uses ePID closed loop system.

The registry classes the interventions as device and drug.

More on the Plan

To investigate the effect of rHuPH20, an adjuvant that accelerates the dispersion and absorption of subcutaneously injected or infused drugs, on mitigating post-prandial blood glucose excursions when injected separately or co-formulated with insulin during closed-loop therapy for youth and young adults with type 1 diabetes.

Closed-loop control will be achieved using external subcutaneous real-time continuous glucose monitoring and continuous subcutaneous insulin infusion along with a computerized algorithm to link these two processes.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex aged from 12 years up to 40 years.

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

Examples of who could join: Age 12-40 years. Clinical diagnosis of T1D based on ADA criteria or presence of DKA at diagnosis (formal antibody and/or genetic testing will not be required). Duration of T1D ≥ 1 year. Treated with CSII for at least 3 months. Body weight \> 37 kg (to accommodate phlebotomy).

The full record lists 9 inclusion and 11 exclusion criteria; among the exclusions: previous allergic reaction to ph20; inability to comprehend written or spoken english; presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct.

How the Study Was Run

It was run as a non-randomized, crossover and open-label study.

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

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 2013-09 with completion listed for 2015-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between CL alone and CL+PH20preRx and CL+INS-PH20 (time frame: during each admission for 3 consecutive study visit days).

It also tracked 1 secondary outcome, for example Peak post-prandial insulin levels following meals.

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Insulin Lispro in 13 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.