Cystic Fibrosis (CF) Exacerbation and Insulin Treatment

What Was Tested

In this not phased trial, researchers set out to test Insulin Aspart and Insulin Lispro.

It had 1 arm (groups): insulin (experimental).

Patients who will get insulin with main meals during Intravenous (IV) antibiotic therapy due to pulmonary exacerbation.

The registry classes the interventions as drug.

More on the Plan

CFRD is primarily an insulinopenic condition characterized by an impaired and delayed insulin secretion, as a consequence of fibrosis in the exocrine pancreatic tissue that compromises the ß-cell function.

Based on data from the CF Patients Registry in the USA, the mortality rate of patients with CFRD is six-fold higher than that of patients without CFRD.

Their pilot study proved that during pulmonary exacerbation (PE), CF patients with Normal Glucose Tolerance (NGT) exhibited early latent diabetic glucose intolerance in Oral Glucose Tolerance Test(OGTT) which becomes completely normalized 3-4 weeks after resolution of PE.

These patients who are considered to be normoglycemic may experience relatively long periods of hyperglycemia during recurrent events of pulmonary infections.

Who Took Part

Enrollment: 30 planned participants were the target.

It was open to people of any sex aged from 10 years with no upper age limit.

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

Examples of who could join: Confirmed diagnosis of CF according to standard criteria. Age \> 10 years. Normal oral glucose tolerance test (OGTT) in the past 12 month. Acute pulmonary exacerbation (PE) according to the treating physician requires treatment with intravenous antibiotics.

The full record lists 5 inclusion and 1 exclusion criteria; among the exclusions: CF-related diabetes/impaired glucose tolerance test (IGTT) in a mixed meal tolerance test performed during full remission from pulmonary exacerbation.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2010-06 with completion listed for 2015-06.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example change in Body Mass Index (BMI).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart and Insulin Lispro in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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