Insulin Glargine Vs Standard Insulin Therapy

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

The registry classes the interventions as drug.

More on the Plan

The majority of cystic fibrosis (CF) patients now survive beyond childhood, and CF related diabetes (CFRD), due to insulin deficiency, is common.

Standard insulin therapy has relied primarily on meal coverage with rapid-acting insulin.

The practice of providing minimal basal insulin in CFRD is based on the fact that most of these patients, unless they are acutely ill, are able to maintain relatively normal blood glucose levels during the day without it.

This practice, which is based on practical clinical considerations, ignores the established relationship between insulin deficiency and clinical deterioration in CFRD.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 12 years with no upper age limit.

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

Examples of who could join: . The diagnosis must be made at a time when the patient is in his/her basal state of health with no evidence of acute exacerbation in the preceding two months. Age ≥18, post-pubertal (done growing, since change in weight is a study endpoint). Willingness to attend all study visits and to engage in regular phone or e-mail contact with the study diabetes nurse.

The full record lists 11 inclusion and 6 exclusion criteria; among the exclusions: pregnancy or plans to become pregnant in the next eight months (because of the changes pregnancy would cause in our study endpoints),; unwillingness / inability to take multiple injections or to count carbohydrates,; A history of hypoglycemia unawareness (rare in CF),.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

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

It started in 2003-04 with completion listed for 2005-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hemoglobin A1c.

It also tracked 4 secondary outcomes, for example BMI, Body composition by DEXA Scan, # Episodes of illness and Quality of life survey.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 20 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.