Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia

What Was Tested

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

No consensus guidelines exist for management of post-transplant glucocorticoid induced hyperglycemia, but most published reviews recommend insulin as first line therapy.

A variety of insulin regimens have been proposed, including mealtime short-acting regular or analog insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal insulin alone such as glargine or detemir.

It had three arms (groups): Neutral protamine hagedorn (NPH) insulin (active comparator), Regular or Aspart insulin (experimental) and Insulin glargine (experimental).

The registry classes the interventions as drug.

Who Took Part

5 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: Have undergone bone marrow, liver, lung, or renal transplant. Have pre-existing or newly diagnosed diabetes mellitus established by any of the criteria listed below:. Be eating meals by mouth.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: heart, pancreas, islet cell transplant recipients; previous use of basal-bolus or pre-mixed insulin regimen; diabetes mellitus type i.

How the Study Was Run

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

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

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

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

It started in 2012-08 with completion listed for 2013-04.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Blood glucose - inpatient (time frame: Time (days) from enrollment to described treatment range, an expected average of 7 days).

It also tracked 13 secondary outcomes, for example Blood glucose - inpatient, Post prandial blood glucose - inpatient, Blood glucose, Hemoglobin A1C, Post prandial blood glucose and Hypoglycemic episodes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 5 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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