Diabetes MellitusPhase 4NCT01963728
Comparison of Insulin Therapy in Treating Post-Transplant Diabetes
A Phase 4 study testing Insulin, Isophane and insulin glargine in people with Diabetes Mellitus, run by Inova Health Care Services at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Insulin, Isophane and insulin glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2013to 9 Apr 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Use of insulin or non-insulin hypoglycemic medication before transplantation
- Cystic fibrosis patients
- Age < 18 years of age
- Pregnancy
- Non-English speaking subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Fairfax Hospital
Falls Church, Virginia, 22042
About this study
Official title: Comparison of Insulin Isophane (NPH) With Insulin Glargine in New Onset Diabetes After Transplant (NODAT)
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).
Read the 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).
- Conditions
- Diabetes Mellitus
- Being tested
- Insulin, Isophane, insulin glargine
- Keywords
- post-transplant, diabetes mellitus, renal transplant, kidney transplant, lung transplant, heart transplant, insulin
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin, IsophaneDrug
Also called human NPH
daily dosing based on fasting morning glucose levels
insulin glargineDrug
Also called Lantus
daily dose based on fasting morning glucose levels
| Study group | Role | What they receive |
|---|---|---|
| insulin isophane | Active comparator | daily dose will be titrated based on fasting morning glucose values Receives: Drug: Insulin, Isophane |
| insulin glargine | Active comparator | daily dose will be titrated based on fasting morning glucose values Receives: Drug: insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1C (Glycosylated Hemoglobin)
Measured: at 6 months post enrollment
Secondary outcomes (1)
Mean Blood Glucose Values
measured by continuous glucose monitoring for 5 days
Measured: 3 and 6 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study start27 Nov 2013
- Primary completion9 Apr 2015
- Study completion9 Apr 2015
Why it stopped: Blood sugar status of the enrolled subjects wasn't evaluable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Ross, MD, Principal investigator, Inova Healthcare Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963728
- Sponsor's protocol ID
- Inova NODAT-001
- Status last verified
- Jul 2022
- First submitted
- 10 Oct 2013
- Last updated
- 26 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There is no data to share
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Insulin Isophane (NPH) With Insulin Glargine in New Onset Diabetes After Transplant (NODAT)
- ClinicalTrials.gov ID
- NCT01963728
- Acronym / sponsor ID
- Inova NODAT-001
- Conditions
- Diabetes Mellitus
- Keywords
- post-transplant, diabetes mellitus, renal transplant, kidney transplant, lung transplant, heart transplant, insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Blood sugar status of the enrolled subjects wasn't evaluable
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 27 Nov 2013 (actual)
- Primary completion
- 9 Apr 2015 (actual)
- Study completion
- 9 Apr 2015 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Posted 12 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin isophane | Active comparator | Drug: Insulin, Isophanedaily dose will be titrated based on fasting morning glucose values |
| insulin glargine | Active comparator | Drug: insulin glarginedaily dose will be titrated based on fasting morning glucose values |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Use of insulin or non-insulin hypoglycemic medication before transplantation
- Cystic fibrosis patients
- Age < 18 years of age
- Pregnancy
- Non-English speaking subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin, IsophaneAlso: human NPHdaily dosing based on fasting morning glucose levels | Drug | insulin isophane |
| insulin glargineAlso: Lantusdaily dose based on fasting morning glucose levels | Drug | insulin glargine |
Primary outcome
Change in Hemoglobin A1C (Glycosylated Hemoglobin)
Time frame: at 6 months post enrollment
1 secondary outcome
Mean Blood Glucose Values
Time frame: 3 and 6 months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no data to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Ross, MD principal investigator
Inova Healthcare Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin, Isophane and insulin glargine in people with Diabetes Mellitus, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1C (Glycosylated Hemoglobin) (time frame: at 6 months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.