Comparison of Insulin Therapy in Treating Post-Transplant Diabetes
Study Details
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: insulin isophane daily dose will be titrated based on fasting morning glucose values |
Drug: Insulin, Isophane
daily dosing based on fasting morning glucose levels
Other Names:
|
Active Comparator: insulin glargine daily dose will be titrated based on fasting morning glucose values |
Drug: insulin glargine
daily dose based on fasting morning glucose levels
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Hemoglobin A1C (Glycosylated Hemoglobin) [at 6 months post enrollment]
Secondary Outcome Measures
- Mean Blood Glucose Values [3 and 6 months post enrollment]
measured by continuous glucose monitoring for 5 days
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Inova Fairfax Hospital | Falls Church | Virginia | United States | 22042 |
Sponsors and Collaborators
- Inova Health Care Services
Investigators
- Principal Investigator: Peter Ross, MD, Inova Healthcare Services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Inova NODAT-001
Study Results
Participant Flow
Recruitment Details | Medical Clinic |
---|---|
Pre-assignment Detail |
Arm/Group Title | Insulin Isophane | Insulin Glargine |
---|---|---|
Arm/Group Description | daily dose will be titrated based on fasting morning glucose values Insulin, Isophane: daily dosing based on fasting morning glucose levels | daily dose will be titrated based on fasting morning glucose values insulin glargine: daily dose based on fasting morning glucose levels |
Period Title: Overall Study | ||
STARTED | 0 | 1 |
COMPLETED | 0 | 0 |
NOT COMPLETED | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Insulin Isophane | Insulin Glargine | Total |
---|---|---|---|
Arm/Group Description | daily dose will be titrated based on fasting morning glucose values Insulin, Isophane: daily dosing based on fasting morning glucose levels | daily dose will be titrated based on fasting morning glucose values insulin glargine: daily dose based on fasting morning glucose levels | Total of all reporting groups |
Overall Participants | 0 | 1 | 1 |
Age (Count of Participants) | |||
<=18 years |
0
NaN
|
0
0%
|
0
0%
|
Between 18 and 65 years |
0
NaN
|
1
100%
|
1
100%
|
>=65 years |
0
NaN
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | |||
Female |
0
NaN
|
1
100%
|
1
100%
|
Male |
0
NaN
|
0
0%
|
0
0%
|
Race and Ethnicity Not Collected (Count of Participants) | |||
Count of Participants [Participants] |
0
NaN
|
||
Region of Enrollment (Count of Participants) | |||
United States |
1
Infinity
|
1
100%
|
|
basal insulin types administered (basal insulin type) [Number] | |||
Number [basal insulin type] |
1
|
1
|
Outcome Measures
Title | Change in Hemoglobin A1C (Glycosylated Hemoglobin) |
---|---|
Description | |
Time Frame | at 6 months post enrollment |
Outcome Measure Data
Analysis Population Description |
---|
study terminated early |
Arm/Group Title | Insulin Isophane | Insulin Glargine |
---|---|---|
Arm/Group Description | daily dose will be titrated based on fasting morning glucose values Insulin, Isophane: daily dosing based on fasting morning glucose levels | daily dose will be titrated based on fasting morning glucose values insulin glargine: daily dose based on fasting morning glucose levels |
Measure Participants | 0 | 0 |
Title | Mean Blood Glucose Values |
---|---|
Description | measured by continuous glucose monitoring for 5 days |
Time Frame | 3 and 6 months post enrollment |
Outcome Measure Data
Analysis Population Description |
---|
No data study did not complete |
Arm/Group Title | Insulin Isophane | Insulin Glargine |
---|---|---|
Arm/Group Description | daily dose will be titrated based on fasting morning glucose values Insulin, Isophane: daily dosing based on fasting morning glucose levels | daily dose will be titrated based on fasting morning glucose values insulin glargine: daily dose based on fasting morning glucose levels |
Measure Participants | 0 | 0 |
Adverse Events
Time Frame | Adverse events collected over the 6 months each subject enrolled | |||
---|---|---|---|---|
Adverse Event Reporting Description | none reported | |||
Arm/Group Title | Insulin Isophane | Insulin Glargine | ||
Arm/Group Description | daily dose will be titrated based on fasting morning glucose values Insulin, Isophane: daily dosing based on fasting morning glucose levels | daily dose will be titrated based on fasting morning glucose values insulin glargine: daily dose based on fasting morning glucose levels | ||
All Cause Mortality |
||||
Insulin Isophane | Insulin Glargine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/1 (0%) | ||
Serious Adverse Events |
||||
Insulin Isophane | Insulin Glargine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/1 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Insulin Isophane | Insulin Glargine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/1 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Anne Whitney Brown, MD Principal Investigator |
---|---|
Organization | Inova Health Care System |
Phone | 703.776.3067 |
anne.brown@inova.org |
- Inova NODAT-001