Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD)

What Was Tested

This registered phase 2, phase 3 trial tested Insulin Detemir.

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

The registry classes the interventions as drug.

More on the Plan

The 1998 North American CF Foundation on CFRD categorized the disease differently than other types of diabetes: CFRD with fasting hyperglycemia (FH), CFRD without FH and transient CFRD.

The outcome of this consensus conference was the use of insulin as the only recommended treatment of CFRD.

Although the conference report mandated treatment for CFRD with FH, treatment was not mandated for the other types of CFRD, the choice to treat was left to the clinician's discretion.

However, insulin was the only recommended therapy for all types of CFRD.

Who Took Part

Enrollment: 6 actual participants took part.

It was open to people of any sex aged from 16 years up to 45 years.

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

Examples of who could join: Patients diagnosed with CFRD by oral glucose tolerance test (OGTT) who are medically stable. Medical stability will be defined as:.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: use of oral or intravenous corticosteroid medications within six weeks of the study; colonization with burkholderia cepacia; colonization with aspergillus.

How the Study Was Run

It was run as a single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-08 with completion listed for 2010-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Blood Sugar (time frame: 6 months).

It also tracked 1 secondary outcome, for example Lean Body Mass.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3 trial of Insulin Detemir in 6 people.

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

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

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