Randomized, Double-blind, Crossover, Pharmacokinetic (PK) and Glucodynamic (GD) Study of Continuous Subcutaneous Insulin Infusion (CSII) in Participants With Type 1 Diabetes Mellitus (T1DM)

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

The purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20) will change the exposure and action of approved insulin analogs when given by continuous subcutaneous insulin infusion (CSII) in participants with Type 1 diabetes mellitus (T1DM).

This study is divided into Stage 1, 2, and 3.

It had four arms (groups): Stage 1: Insulin aspart first, then insulin aspart-rHuPH20 (active comparator), Stage 1: Insulin aspart-rHuPH20 first, then insulin aspart (active comparator), Stage 3: Insulin aspart first, then insulin aspart + rHuPH20 (active comparator) and Stage 3: Insulin aspart + rHuPH20 first, then insulin aspart (active comparator).

The registry classes the interventions as drug.

Who Took Part

45 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Body mass index (BMI) 18.0 to 35.0 kilograms per meter squared (kg/m\^2), inclusive. Fasting C-peptide \<0.6 nanograms per milliliter (ng/mL). Routine use of continuous subcutaneous insulin infusion (CSII) as the primary route of insulin administration.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: known or suspected allergy to any component of any of the study drugs in this trial; previous enrollment in this trial (exception: participants in stage 1 are permitted to participate in stage 2); use of any long-acting insulin injection within 72 hours of stage 1 or stage 3.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

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

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

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2011-01 with completion listed for 2011-12.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Early Insulin Exposure (%AUC[0-60]), Stage 1 (time frame: 10 minutes predose up to 60 minutes postdose). Early Exposure to Insulin (%AUC[0-60]), Stage 3 (time frame: 10 minutes predose up to 60 minutes postdose on Days 2/7, 3/8, and 5/10).

It also tracked 12 secondary outcomes, for example Maximum Glucose Infusion Rate (GIRmax), Stage 1, Maximum Glucose Infusion Rate (GIRmax), Stage 3, Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 1, Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 3, Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 1 and Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 3.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 45 people.

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

More context: the Insulin Aspart compound page, all human trials.