Comparison of Insulin Therapy in Treating Post-Transplant Diabetes

Phase 4

Terminated

• Conditions: Diabetes Mellitus
• Interventions: Drug: Insulin, Isophane; Drug: insulin glargine

• Registration Number: NCT01963728
• Lead Sponsor: Inova Health Care Services

Brief 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).

Study Timeline

• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Study Start: 2013-11-27
• Primary Completion: 2015-04-09
• Study Completion: 2015-04-09
• Results First Submitted: 2017-08-15
• Results First Submitted QC: 2021-12-23
• Results First Posted: 2022-01-12
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
insulin isophane	Insulin, Isophane	daily dose will be titrated based on fasting morning glucose values
insulin glargine	insulin glargine	daily dose will be titrated based on fasting morning glucose values

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1C (Glycosylated Hemoglobin)	at 6 months post enrollment

Secondary Outcome Measures

Name	Time	Method
Mean Blood Glucose Values	3 and 6 months post enrollment	measured by continuous glucose monitoring for 5 days

Trial Locations

Locations (1)

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States