Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia (PTHG)

Vancouver General Hospital

Status and phase: Terminated; Phase 4

Conditions: Post-Transplant Glucocorticoid Induced Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01648218

PTHG.VGH.UBC

Details and patient eligibility

About

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?

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 3 patient groups

Neutral protamine hagedorn (NPH) insulin

Active Comparator group

Description:

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.

Treatment:

Drug: Neutral protamine hagedorn (NPH) insulin

Regular or Aspart insulin

Experimental group

Description:

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.

Treatment:

Drug: Regular human insulin or Insulin Aspart

Insulin glargine

Experimental group

Description:

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.

Treatment:

Drug: Insulin glargine