drugset / Trial / NCT01648218

Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia

NCT01648218

Phase 4 Terminated 5 enrolled Vancouver General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

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. However, no randomized trial has ever examined different insulin regimens to determine which most effectively controls post-transplant steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three commonly used insulin regimens used for managing post-transplant once-daily glucocorticoid-induced hyperglycemia to determine which is most effective: * Group 1: Intermediate-acting (NPH) insulin at breakfast * Group 2: Short-acting insulin (regular or aspart) before meals * Group 3: Insulin glargine at breakfast Question/Hypothesis: Among three commonly used insulin regimens, which is most effective for managing post-transplant once-daily glucocorticoid-induced hyperglycemia?

Timeline

Start
2012-08
Primary completion
2013-04
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic Subcutaneous
Comparator Neutral Protamine Hagedorn (NPH) insulin Protein / enzyme biologic Subcutaneous
Subject insulin aspart Protein / enzyme biologic Subcutaneous
Subject insulin glargine Protein / enzyme biologic Subcutaneous

Indications

No indication recorded.