Comparison of Insulin Therapy in Treating Post-Transplant Diabetes
Primary Purpose
Diabetes Mellitus
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Insulin, Isophane
insulin glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring post-transplant, diabetes mellitus, renal transplant, kidney transplant, lung transplant, heart transplant, insulin
Eligibility Criteria
Inclusion Criteria:
- Must be followed by the Inova Fairfax Hospital transplantation program for post-transplant care
- Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication
- Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if it was required)
- Ability to read consent form and give consent in English.
Exclusion Criteria:
- Use of insulin or non-insulin hypoglycemic medication before transplantation
- Cystic fibrosis patients
- Age < 18 years of age
- Pregnancy
- Non-English speaking subjects
Sites / Locations
- Inova Fairfax Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
insulin isophane
insulin glargine
Arm Description
daily dose will be titrated based on fasting morning glucose values
daily dose will be titrated based on fasting morning glucose values
Outcomes
Primary Outcome Measures
Change in Hemoglobin A1C (Glycosylated Hemoglobin)
Secondary Outcome Measures
Mean Blood Glucose Values
measured by continuous glucose monitoring for 5 days
Full Information
NCT ID
NCT01963728
First Posted
October 10, 2013
Last Updated
July 19, 2022
Sponsor
Inova Health Care Services
1. Study Identification
Unique Protocol Identification Number
NCT01963728
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Blood sugar status of the enrolled subjects wasn't evaluable
Study Start Date
November 27, 2013 (Actual)
Primary Completion Date
April 9, 2015 (Actual)
Study Completion Date
April 9, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
post-transplant, diabetes mellitus, renal transplant, kidney transplant, lung transplant, heart transplant, insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Subjects will be randomized to
Insulin glargine (Lantus) or
Insulin isophane (NPH)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
insulin isophane
Arm Type
Active Comparator
Arm Description
daily dose will be titrated based on fasting morning glucose values
Arm Title
insulin glargine
Arm Type
Active Comparator
Arm Description
daily dose will be titrated based on fasting morning glucose values
Intervention Type
Drug
Intervention Name(s)
Insulin, Isophane
Other Intervention Name(s)
human NPH
Intervention Description
daily dosing based on fasting morning glucose levels
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Other Intervention Name(s)
Lantus
Intervention Description
daily dose based on fasting morning glucose levels
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1C (Glycosylated Hemoglobin)
Time Frame
at 6 months post enrollment
Secondary Outcome Measure Information:
Title
Mean Blood Glucose Values
Description
measured by continuous glucose monitoring for 5 days
Time Frame
3 and 6 months post enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be followed by the Inova Fairfax Hospital transplantation program for post-transplant care
Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication
Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if it was required)
Ability to read consent form and give consent in English.
Exclusion Criteria:
Use of insulin or non-insulin hypoglycemic medication before transplantation
Cystic fibrosis patients
Age < 18 years of age
Pregnancy
Non-English speaking subjects
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Ross, MD
Organizational Affiliation
Inova Healthcare Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no data to share
Learn more about this trial
Comparison of Insulin Therapy in Treating Post-Transplant Diabetes
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