The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients

What Was Tested

The trial (phase 2, phase 3) is built around Insulin Aspart and Insulin Detemir.

It had four arms (groups): placebo (placebo comparator), basal insulin levemir (experimental), rapid-acting insulin Novolog (experimental) and Healthy controls (no intervention).

Once or 3x daily injectable placebo (insulin diluent).

Once daily basal insulin therapy with insulin levemir.

Pre-meal rapid-acting insulin 3x/day with insulin novolog.

The registry classes the interventions as drug.

More on the Plan

Insulin insufficiency related to pancreatic fibrosis and β-cell dysfunction is present in almost every cystic fibrosis (CF) patient.

Progressive abnormalities in insulin secretion begin in childhood, and, in adults, CF related diabetes (CFRD) is eventually present in more than half of the CF population.

The negative consequences of diabetes are just the "tip of the iceberg", since clinical deterioration has been documented to begin in the pre-diabetic period.

Insulin is a potent anabolic hormone, critical for maintenance of body weight and muscle mass.

Who Took Part

65 actual participants took part.

It was open to people of any sex aged from 10 years up to 25 years.

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

Examples of who could join: Diagnosis of cystic fibrosis, age 10-25 years. A standard routine annual OGTT performed within 12 months of randomization.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: diagnosis of cfrd, consensus conference definition (45); previous organ transplant, or transplant imminent during study period; BMI percentile \>95.

How the Study Was Run

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

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

The Insulin Aspart 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 Aspart.

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

It started in 2015-08 with completion listed for 2022-07.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Endogenous Protein Breakdown (Flux) After 4 Weeks of Insulin/Placebo Therapy, CF Patients (time frame: 4 weeks).

It also tracked 1 secondary outcome, for example Baseline Protein Turnover (Flux), CF Patients vs Healthy Controls.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 65 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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