Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia

NCT ID: NCT01648218

Last Updated: 2015-12-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-06-30

Brief 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?

Conditions

Post-Transplant Glucocorticoid Induced Diabetes

Keywords

glucocorticoid; diabetes mellitus; post-transplant; insulin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neutral protamine hagedorn (NPH) insulin

Drug: Neutral protamine hagedorn (NPH) insulin

Other Names:

Humulin N, Novolin N

Route: Subcutaneous; Dosage: No fixed dose, varies between subjects; Frequency: daily before breakfast; Duration: 12 hours; for duration subjects are concurrently administered once-daily glucocorticoid.

Group Type: ACTIVE_COMPARATOR

Neutral protamine hagedorn (NPH) insulin

Intervention Type: DRUG

Regular or Aspart insulin

Drug: Regular human insulin or Insulin Aspart

Other Names:

Humulin R, Novolin R, Novolog, NovoRapid

Route: Subcutaneous; Dosage: No fixed dose, varies between subjects; Frequency: daily before meals; Duration: 2 hours (Aspart) or 6 hours (Regular); for duration subjects are concurrently administered once-daily glucocorticoid.

Group Type: EXPERIMENTAL

Regular human insulin or Insulin Aspart

Intervention Type: DRUG

Insulin glargine

Drug: Insulin glargine

Other Names:

Lantus

Route: Subcutaneous; Dosage: No fixed dose, varies between subjects; Frequency: daily before breakfast; Duration: 24 hours; for duration subjects are concurrently administered once-daily glucocorticoid.

Group Type: EXPERIMENTAL

Insulin glargine

Intervention Type: DRUG

Interventions

Neutral protamine hagedorn (NPH) insulin

Intervention Type: DRUG

Regular human insulin or Insulin Aspart

Intervention Type: DRUG

Insulin glargine

Intervention Type: DRUG

Other Intervention Names

Humulin N, Novolin N; Humulin R; Novolin R; Novolog; NovoRapid; Lantus

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vancouver General Hospital

OTHER

Sponsor Role: lead

Responsible Party

David E. Harris, MD

MD, FRCPC, Clinical Endocrinology Fellow, University of British Columbia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Breay W Paty, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Vancouver General Hospital, University of British Columbia

Locations

Vancouver General Hospital - Jim Pattison Pavilion

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 22058376 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22475764 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20439241 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22049542 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22223765 (View on PubMed)

Related Links

http://www.diabetes.ca/diabetes-and-you/nutrition/just-basics/

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

Other Identifiers

PTHG.VGH.UBC

Identifier Type: -

Identifier Source: org_study_id