Dose-Ranging, Pharmacokinetic (PK), Glucodynamic (GD), Safety and Tolerability Study of Subcutaneously (SC) Administered Humulin R and Humalog With or Without rHuPH20

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Lispro.

The registry classes the interventions as drug.

More on the Plan

Subjects will be enrolled in one of four sequential study stages.

In each stage, a euglycemic clamp procedure will be used to control plasma glucose levels.

Blood samples will be collected over an 8-hour time period after insulin administration (either Humulin R or Humalog) to analyze insulin and glucose levels using fully validated methods.

Glucose infusion rates (GIR) will be recorded throughout the study period.

Who Took Part

The registry lists 42 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: BMI between 18-28 kg/m2, inclusive. Total body weight \>70 kg (154 lb) for men and 46 kg (101 lb) for women. Subject willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including adequate venous access. A negative serum pregnancy test (if female of childbearing potential) within 14 days of study drug injection. Decision-making capacity and willingness and ability to comply with the requirements for full completion of the study.

The full record lists 11 inclusion and 12 exclusion criteria; among the exclusions: known history of diabetes mellitus or gestational diabetes; known allergy to hyaluronidase or any other ingredient in the study drug; positive hiv 1 and hiv 2 (human immunodeficiency virus) antibody test, hepatitis b (anti-hbsag) or hepatitis c (anti-hcv) antibody test.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Insulin Lispro was given.

Those kept unaware of assignments: participant.

It started in 2008-11 with completion listed for 2009-08-28.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Insulin AUC (time frame: 0 to 60 minutes).

It also tracked 1 secondary outcome, for example Other insulin PK, GD and safety outcomes.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 42 people.

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.