Comparison of Insulin Therapy in Treating Post-Transplant Diabetes

Study Overview
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Brief Summary
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To determine if the use of insulin isophane results in improved control of blood sugars compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart transplantation (NODAT).

Detailed Description
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A large percentage of organ transplant recipients develop de novo diabetes mellitus after transplantation, also called New Onset Diabetes After Transplant or NODAT. The cause of the diabetes appears to be commonly used anti-rejection medications, particularly calcineurin inhibitors and glucocorticoids. Management of glucose levels in NODAT often requires insulin therapy. Standard practice is to start long-acting insulin. However, patients with NODAT often exhibit fasting morning glucose levels that are relatively low compared to pre-lunch and pre-dinner glucose levels. This seems to make NODAT patients more susceptible to fasting, or morning, hypoglycemia on long-acting insulin analogues than non-transplant patients with type II diabetes. This phenomenon of morning hypoglycemia in NODAT often limits the up-titration of basal insulin resulting in suboptimal treatment of hyperglycemia later in the day. Because of this pattern, transplant patients may respond better to morning insulin isophane (intermediate acting) than to long-acting insulin glargine preparations. Our trial is designed to compare morning NPH insulin (isophane insulin) with conventional therapy of basal glargine insulin on both continuous blood glucose levels and hemoglobin A1c (glycosylated hemoglobin).

Official Title
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Comparison of Insulin Isophane (NPH) With Insulin Glargine in New Onset Diabetes After Transplant (NODAT)

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin, Isophane
* Drug: insulin glargine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be followed by the Inova Fairfax Hospital transplantation program for post-transplant care Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if it was required) Ability to read consent form and give consent in English. Exclusion Criteria: Use of insulin or non-insulin hypoglycemic medication before transplantation Cystic fibrosis patients Age < 18 years of age Pregnancy Non-English speaking subjects

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: insulin isophane<br>daily dose will be titrated based on fasting morning glucose values | Drug: Insulin, Isophane<br>* daily dosing based on fasting morning glucose levels<br>* Other names: human NPH;|
| Active Comparator: insulin glargine<br>daily dose will be titrated based on fasting morning glucose values | Drug: insulin glargine<br>* daily dose based on fasting morning glucose levels<br>* Other names: Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1C (Glycosylated Hemoglobin) |  | at 6 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Blood Glucose Values | measured by continuous glucose monitoring for 5 days | 3 and 6 months post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-transplant, diabetes mellitus, renal transplant, kidney transplant, lung transplant, heart transplant, insulin