Comparison of Insulin Therapy in Treating Post-Transplant Diabetes

NCT ID: NCT01963728

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-27
• Study Completion Date: 2015-04-09

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).

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

insulin isophane

daily dose will be titrated based on fasting morning glucose values

Group Type: ACTIVE_COMPARATOR

Insulin, Isophane

Intervention Type: DRUG

daily dosing based on fasting morning glucose levels

insulin glargine

daily dose will be titrated based on fasting morning glucose values

Group Type: ACTIVE_COMPARATOR

insulin glargine

Intervention Type: DRUG

daily dose based on fasting morning glucose levels

Interventions

Insulin, Isophane

daily dosing based on fasting morning glucose levels

Intervention Type: DRUG

insulin glargine

daily dose based on fasting morning glucose levels

Intervention Type: DRUG

Other Intervention Names

human NPH; Lantus

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Ross, MD

Role: PRINCIPAL_INVESTIGATOR

Inova Healthcare Services

Locations

Inova Fairfax Hospital

Falls Church, Virginia, United States

Countries

United States

Other Identifiers

Inova NODAT-001

Identifier Type: -

Identifier Source: org_study_id