Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 2) is built around Insulin (regular human) and Insulin Glargine.

Insulin lispro is approved by the Food and Drug Administration (FDA) for the treatment of diabetes mellitus.

Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs.

In this study, rHuPH20 combined with a non-preserved (NP) formulation of regular human insulin (INSULIN-PH20 NP) will be compared to insulin lispro with respect to absorption and action of insulin.

It had 1 arm (groups): INSULIN-PH20 NP / Insulin Lispro (experimental).

The registry classes the interventions as drug.

More on the Plan

The purpose of this study is to compare the safety and tolerability of INSULIN-PH20 NP versus insulin lispro alone.

Who Took Part

The registry lists 48 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: Participants with Type 1 diabetes mellitus (T1DM) (per World Health Organization \[WHO\] criteria) treated with insulin for ≥24 months. Participants who use an insulin infusion pump for basal insulin administration must be on the device for at least 90 days prior to screening. Body mass index (BMI) 18.0 to 35.0 kilograms per square meter (kg/m\^2), inclusive. Fasting C-peptide \<0.6 nanograms per milliliter (ng/mL).

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: known or suspected allergy to any component of any of the study drugs in this study; previous enrollment in this study. participants who fail screening may attempt to rescreen into the study; A participant who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.

How the Study Was Run

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

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

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

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

It started in 2009-05 with completion listed for 2010-02.

It ran at 8 sites in United States (8).

What Was Measured

Primary outcome: Postprandial Glucose Excursion (time frame: Week 14 and Week 26).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) and Insulin Glargine in 48 people.

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

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