Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human).

It had two arms (groups): 1 (experimental) and 2 (no intervention).

Insulin yes.

Insulin no.

The registry classes the interventions as drug.

More on the Plan

Eligible patients who will accept to participate to this study will be randomly allocated in the group who will or will not receive glargine as additional supportive therapy.

Patients will in any case continue the CF therapy prescribed by their treating physicians and their usual diet.

All the patients will be evaluated every three months to assess their nutritional, pulmonary and glycometabolic status.

The follow-up will continue until the 18th month after the study entry.

Who Took Part

The registry lists 70 planned participants were the target.

It was open to people of any sex aged from 10 years up to 70 years.

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

Examples of who could join: Ascertained diagnosis of CF. Age ≥ 10 years. At least one of the following conditions:. BMI (body mass index) \< 10th centile for age and sex (according to Rolland Cachera 1991). Loss of one BMI centile class for age and sex in the last year (according to Rolland Cachera 1991).

The full record lists 8 inclusion and 1 exclusion criteria; among the exclusions: specific contraindications for the use of glargine.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2005-08 with completion listed for 2009-10.

It ran at 6 sites in Italy (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Nutritional status evaluated as variations of Z score of BMI (time frame: At recruitment time and at +3, +6, +9, +12, +15, +18 months).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 70 people.

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

More context: the Insulin (regular human) compound page, all human trials.