Comparison of Insulin Therapy in Treating Post-Transplant Diabetes

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01963728
• Other study ID #: Inova NODAT-001
• Status: Terminated
• Phase: Phase 4
• Start date: November 27, 2013
• Est. completion date: April 9, 2015

Study information

• Verified date: July 2022
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 9, 2015
• Est. primary completion date: April 9, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Insulin, Isophane
daily dosing based on fasting morning glucose levels
• insulin glargine
daily dose based on fasting morning glucose levels

Locations

Country	Name	City	State
United States	Inova Fairfax Hospital	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1C (Glycosylated Hemoglobin)		at 6 months post enrollment
Secondary	Mean Blood Glucose Values	measured by continuous glucose monitoring for 5 days	3 and 6 months post enrollment