Clinical trial NCT01963728: Comparison of Insulin Therapy in Treating Post-Transplant Diabetes
Official title: Comparison of Insulin Isophane (NPH) With Insulin Glargine in New Onset Diabetes After Transplant (NODAT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: post-transplant
diabetes mellitus
renal transplant
kidney transplant
lung transplant
heart transplant
insulin
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in Hemoglobin A1C (Glycosylated Hemoglobin)
timeFrame: at 6 months post enrollment
Secondary outcomes:
measure: Mean Blood Glucose Values
timeFrame: 3 and 6 months post enrollment
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: Inova Healthcare Services
name: Peter Ross, MD
role: PRINCIPAL_INVESTIGATOR
References: