Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

What Was Tested

The trial (phase 3) is built around Insulin (regular human).

Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus?

That is the question examined in the phase III trial.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

Repaglinide; oral.

Short-acting Insulin (Actrapid).

The registry classes the interventions as drug.

More on the Plan

Diabetes mellitus may be present in patients with cystic fibrosis (mucoviscidosis) starting in the second decade of life.

Several centres report the successful management of CF-related diabetes using oral anti-diabetic drugs at least for some years.

Oral therapies would be less invasive for a patient group which is highly traumatised by a very demanding therapy (multiple drugs including antibiotics, pancreas enzymes, bronchodilators, mucolysis, in addition to physiotherapy, regular inpatient iv-antibiotic therapy etc, finally lung transplants in a subgroup of patients).

Who Took Part

The registry lists 73 actual participants took part.

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: Diagnosed cystic fibrosis. Age 10 years and older. Newly diagnosed Diabetes mellitus in the screening.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: already treated diabetes mellitus by oral antidiabetic medication or insulin; systemic steroid therapy during the last 3 months; transplantation (status post tx or on the waiting list for tx).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2001-09 with completion listed for 2011-12.

It ran at 36 sites in Germany (27), France (6), Austria (2) and Italy (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c (time frame: 2 years).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 73 people.

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

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