DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia

Information source: Vancouver General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-Transplant Glucocorticoid Induced Diabetes

Intervention: Neutral protamine hagedorn (NPH) insulin (Drug); Regular human insulin or Insulin Aspart (Drug); Insulin glargine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Vancouver General Hospital

Official(s) and/or principal investigator(s):
Breay W Paty, MD, FRCPC, Principal Investigator, Affiliation: Vancouver General Hospital, University of British Columbia

Overall contact:
Breay W Paty, MD, FRCPC, Phone: 604-875-5990, Email: breay.paty@vch.ca


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?

Clinical Details

Official title: Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Blood glucose - inpatient

Secondary outcome:

Blood glucose - inpatient

Post prandial blood glucose - inpatient

Length of inpatient hospital stay

Blood glucose

Hemoglobin A1C

Post prandial blood glucose

Hypoglycemic episodes

Glycemic treatment failure

Cardiovascular events

Post-transplant infections or new antibiotic use

Transplant graft failure

New acute renal failure



Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. Have undergone bone marrow, liver, lung, or renal transplant. 2. Be using once daily oral glucocorticoid therapy (total daily dose of Prednisone ≥10 mg, Hydrocortisone ≥40 mg, Dexamethasone ≥1. 5 mg) administered in the morning and expected to continue for at least 2 weeks. 3. Have pre-existing or newly diagnosed diabetes mellitus established by any of the criteria listed below: 1. Fasting plasma glucose ≥7. 0 mmol/L (repeated x 1) 2. Any plasma glucose ≥11. 0 mmol/L 4. Have at least three pre-meal inpatient capillary blood glucose (CBG) readings ≥ 7. 8 mmol/L 5. Be eating meals by mouth Exclusion Criteria: 1. Heart, Pancreas, Islet cell transplant recipients 2. Previous use of Basal-Bolus or Pre-Mixed Insulin regimen 3. Diabetes mellitus type I 4. NPO (not eating meals by mouth) 5. Receiving enteral (tube feeds) or parenteral (TPN) nutrition

Locations and Contacts

Breay W Paty, MD, FRCPC, Phone: 604-875-5990, Email: breay.paty@vch.ca

Vancouver General Hospital - Jim Pattison Pavilion, Vancouver, British Columbia V5Z 1M9, Canada; Recruiting
Breay W Paty, MD, FRCPC, Phone: 604-875-5990, Email: breay.paty@vch.ca
David E Harris, MD, FRCPC, Phone: 778-995-5414, Email: deharris@interchange.ubc.ca
Breay W Paty, MD, FRCPC, Principal Investigator
Additional Information

Multilingual dietary instructions to be distributed to ALL subjects during study from the Canadian Diabetes Association

Related publications:

Lane JT, Dagogo-Jack S. Approach to the patient with new-onset diabetes after transplant (NODAT). J Clin Endocrinol Metab. 2011 Nov;96(11):3289-97. doi: 10.1210/jc.2011-0657.

Sarno G, Muscogiuri G, De Rosa P. New-onset diabetes after kidney transplantation: prevalence, risk factors, and management. Transplantation. 2012 Jun 27;93(12):1189-95. doi: 10.1097/TP.0b013e31824db97d. Review.

Griffith ML, Jagasia M, Jagasia SM. Diabetes mellitus after hematopoietic stem cell transplantation. Endocr Pract. 2010 Jul-Aug;16(4):699-706. doi: 10.4158/EP10027.RA. Review.

Lansang MC, Hustak LK. Glucocorticoid-induced diabetes and adrenal suppression: how to detect and manage them. Cleve Clin J Med. 2011 Nov;78(11):748-56. doi: 10.3949/ccjm.78a.10180. Review.

Umpierrez GE, Hellman R, Korytkowski MT, Kosiborod M, Maynard GA, Montori VM, Seley JJ, Van den Berghe G; Endocrine Society. Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2012 Jan;97(1):16-38. doi: 10.1210/jc.2011-2098.

Starting date: August 2012
Last updated: October 17, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017