Comparison of Insulin Therapy in Treating Post-Transplant Diabetes

Sponsor
Inova Health Care Services (Other)
Overall Status
Terminated
CT.gov ID
NCT01963728
Collaborator
(none)
2
1
2
16.4
0.1

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
  • Drug: Insulin, Isophane
  • Drug: insulin glargine
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

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Subjects will be randomized to Insulin glargine (Lantus) or Insulin isophane (NPH)
Primary Purpose:
Treatment
Official Title:
Comparison of Insulin Isophane (NPH) With Insulin Glargine in New Onset Diabetes After Transplant (NODAT)
Actual Study Start Date :
Nov 27, 2013
Actual Primary Completion Date :
Apr 9, 2015
Actual Study Completion Date :
Apr 9, 2015

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:
  • human NPH
  • 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:
  • Lantus
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Hemoglobin A1C (Glycosylated Hemoglobin) [at 6 months post enrollment]

    Secondary Outcome Measures

    1. Mean Blood Glucose Values [3 and 6 months post enrollment]

      measured by continuous glucose monitoring for 5 days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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.
    Responsible Party:
    Inova Health Care Services
    ClinicalTrials.gov Identifier:
    NCT01963728
    Other Study ID Numbers:
    • Inova NODAT-001
    First Posted:
    Oct 16, 2013
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Inova Health Care Services
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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
    2. Secondary Outcome
    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

    [Not Specified]

    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
    Email anne.brown@inova.org
    Responsible Party:
    Inova Health Care Services
    ClinicalTrials.gov Identifier:
    NCT01963728
    Other Study ID Numbers:
    • Inova NODAT-001
    First Posted:
    Oct 16, 2013
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022