Comparison of Insulin Therapy in Treating Post-Transplant Diabetes

Inova Health Care Services

Status and phase: Terminated; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: Insulin, Isophane; Drug: insulin glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT01963728

Inova NODAT-001

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Must be followed by the Inova Fairfax Hospital transplantation program for post-transplant care
2. Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication
3. Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if it was required)
4. Ability to read consent form and give consent in English.

Exclusion criteria

1. Use of insulin or non-insulin hypoglycemic medication before transplantation
2. Cystic fibrosis patients
3. Age < 18 years of age
4. Pregnancy
5. Non-English speaking subjects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

insulin isophane

Active Comparator group

Description:

daily dose will be titrated based on fasting morning glucose values

Treatment:

Drug: Insulin, Isophane

insulin glargine

Active Comparator group

Description:

daily dose will be titrated based on fasting morning glucose values

Treatment:

Drug: insulin glargine