Study of HDV Insulin Versus Insulin in Type 1 Diabetes Subjects (ISLE-1)

What Was Tested

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

The patients will be randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro).

Both arms will receive the randomized treatment in combination with glargine or detemir.

It had two arms (groups): Test Group (experimental) and Control Group (active comparator).

The registry classes the interventions as drug.

More on the Plan

SCREENING (Visit 1, Week -4 to -1) Patients will arrive for Screening following an 8 hour fast.

During Screening, patients will sign the informed consent form, be reviewed for inclusion/exclusion, and provide medical history, concomitant medications, and demographics.

They will have a brief physical exam and provide vital signs.

Safety hematology/chemistry/urinalysis (with liver enzymes) will include infectious serology, and serum pregnancy test for women of childbearing potential.

Who Took Part

The registry lists 157 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Men and women ≥ 18 yrs. of age. Clinical diagnosis of Type 1 diabetes mellitus for at least 12 months. Body Mass Index (BMI) ≤ 35 Kg/m2. Basal insulin includes insulin Glargine or insulin Detemir. Willingness to adhere to protocol and perform all required tests.

The full record lists 11 inclusion and 20 exclusion criteria; among the exclusions: history of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that effect hba1c measurements; evidence of serious complications of diabetes (eg, symptomatic autonomic neuropathy); patient on low carbohydrate diet, such as atkins diet.

How the Study Was Run

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

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

The Insulin Lispro group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Lispro.

Those kept unaware of assignments: participant and investigator.

It started in 2016-06 with completion listed for 2018-04-28.

It ran at 21 sites in United States (21).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: 26 weeks).

It also tracked 6 secondary outcomes, for example Change in fasting blood glucose glucose levels, Hypoglycemia occurrences by category: Severe, Documented Symptomatic, and Asymptomatic Hypoglycemia, Number of Patients with Adverse Events, Change in total insulin usage, Change in Body Weight and Mean Mixed Meal Tolerance Test.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 157 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.