NCT01963728

Comparison of Insulin Therapy in Treating Post-Transplant Diabetes

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin, Isophane	daily dosing based on fasting morning glucose levels
DRUG	insulin glargine	daily dose based on fasting morning glucose levels

Timeline

• Start date: 2013-11-27
• Primary completion: 2015-04-09
• Completion: 2015-04-09
• First posted: 2013-10-16
• Last updated: 2022-07-26
• Results posted: 2022-01-12

Locations

1 site across 1 country: United States