Comparison of Insulin Therapy in Treating Post-Transplant Diabetes

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

It had two arms (groups): insulin isophane (active comparator) and insulin glargine (active comparator).

The registry classes the interventions as drug.

More on the Plan

The cause of the diabetes appears to be commonly used anti-rejection medications, particularly calcineurin inhibitors and glucocorticoids.

Management of glucose levels in NODAT often requires insulin therapy.

Standard practice is to start long-acting insulin.

However, patients with NODAT often exhibit fasting morning glucose levels that are relatively low compared to pre-lunch and pre-dinner glucose levels.

Who Took Part

The registry lists 2 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication. Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if it was required). Ability to read consent form and give consent in English.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: use of insulin or non-insulin hypoglycemic medication before transplantation; cystic fibrosis patients; age \< 18 years of age.

How the Study Was Run

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

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

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2013-11-27 with completion listed for 2015-04-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Hemoglobin A1C (Glycosylated Hemoglobin) (time frame: at 6 months post enrollment).

It also tracked 1 secondary outcome, for example Mean Blood Glucose Values.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 2 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 Glargine compound page, all human trials.