Prevention of New Onset Diabetes Among Kidney Transplant PatientsPhase 4ITP-NODATNCT01683331

A Clinical Trial to Prevent New Onset Diabetes After Transplantation

A Phase 4 study testing Insulin treatment for hyperglycemia in people with Prevention of New Onset Diabetes Among Kidney Transplant Patients, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Specific Aim 1: To determine the clinical efficacy of early initiation of insulin therapy in decreasing the incidence of NODAT among de novo kidney transplant patients with manifested post-transplant hyperglycemia during the first week after transplantation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Prevention of New Onset Diabetes Among Kidney Transplant Patients
What is being tested?: Insulin treatment for hyperglycemia
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 251 participants
Where: 1 siteUnited States
Study dates: Aug 2012to 27 Feb 2018
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

Adult patients (> 18 years) with end stage renal disease (ESRD) undergoing kidney transplantation;
Standard triple immunosuppressive medications following kidney transplantation including tacrolimus, mycophenolate mofetil and corticosteroids;
Capable to understand the study protocol and to give informed consent;

Who cannot join

1. Type 1 and 2 Diabetes Mellitus (DM) either as co-morbidity or cause of ESRD;

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Hypothesis 1: Early initiation of insulin therapy protects beta-cell from early stress related to the surgery and use of higher doses of immunosuppressive medications, and leads to lower incidence of NODAT at 1 and 2 years.

Specific Aim 2: To determine the improvement in overall glycemic control with the early initiation of insulin therapy.

Hypothesis 2: Early initiation of insulin therapy results in greater overall control of glycemia compared to standard care of dietary counseling, life-style modification, oral hypoglycemic agents and/or insulin as needed at 1 year.

Specific Aim 3: To determine the improvement in beta-cell function among patients assigned to the early initiation of insulin therapy at one year post-transplantation.

Hypothesis 3: Early initiation of insulin therapy protects beta-cell from glucotoxicity of post-transplant hyperglycemia and preserves better beta-cell function at 1 year.

Conditions: Prevention of New Onset Diabetes Among Kidney Transplant Patients
Being tested: Insulin treatment for hyperglycemia
Keywords: Kidney transplant, New onset diabetes, Prevention, Insulin
Medical subject headings: Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin treatment for hyperglycemiaDrug

Study groups in NCT01683331
Study group	Role	What they receive
Insulin treatment for hyperglycemia	Active comparator	Neutral Protamine Hagedorn (NPH) Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG > 240, NPH initiation: 14, dose increases by 4; For pts. with CPG > 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG > 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG > 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG <60 mg/dl, NPH initiation: 0, ½ of previous dose. Receives: Drug: Insulin treatment for hyperglycemia
Standard of care	No intervention	Patients assigned in this arm will receive standard of care following their kidney transplantation.

What is being measured

The primary outcome is the main question the study is designed to answer.

The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation
NODAT will be defined according to American Diabetes Association definition:
1. Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or
2. 2 hours Oral Glucose Tolerance Test (OGTT) values equal or greater than 200 mg/dl; and/or
3. Glycosylated hemoglobin A1c equal or greater than 6.5; and/or
4. On oral hypoglycemic agents and/or insulin therapy; Incidence is measured in terms of number of participants who meet any of these 4 criteria.
Measured: 12 months

Secondary outcomes (1)

The Incidence of New Onset of Diabetes After Transplant (NODAT) 24 Months After Kidney Transplantation
NODAT will be defined according to American Diabetes Association definition:
1. Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or
2. 2 hours OGTT values equal or greater than 200 mg/dl; and/or
3. Glycosylated hemoglobin A1c equal or greater than 6.5; and/or
4. On oral hypoglycemic agents and/or insulin therapy;
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201227 Feb 2018

First posted11 Sep 2012 (estimated)
Study startAug 2012
Primary completion27 Feb 2018
Study completion27 Feb 2018

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 Prevention of New Onset Diabetes Among Kidney Transplant PatientsStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 251 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01683331
Sponsor's protocol ID: 1R01DK092475-01
Acronym: ITP-NODAT
Status last verified: Feb 2019
First submitted: 30 Aug 2012
Last updated: 20 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial to Prevent New Onset Diabetes After Transplantation
ClinicalTrials.gov ID: NCT01683331
Acronym / sponsor ID: ITP-NODAT / 1R01DK092475-01
Conditions: Prevention of New Onset Diabetes Among Kidney Transplant Patients
Keywords: Kidney transplant, New onset diabetes, Prevention, Insulin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 251 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: Medical University of Vienna
Study start: Aug 2012 (actual)
Primary completion: 27 Feb 2018 (actual)
Study completion: 27 Feb 2018 (actual)
First posted: 11 Sep 2012 (estimated)
Results: Posted 20 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Specific Aim 2: To determine the improvement in overall glycemic control with the early initiation of insulin therapy.

Specific Aim 3: To determine the improvement in beta-cell function among patients assigned to the early initiation of insulin therapy at one year post-transplantation.

Hypothesis 3: Early initiation of insulin therapy protects beta-cell from glucotoxicity of post-transplant hyperglycemia and preserves better beta-cell function at 1 year.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Insulin treatment for hyperglycemia	Active comparator	Drug: Insulin treatment for hyperglycemiaNeutral Protamine Hagedorn (NPH) Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG > 240, NPH initiation: 14, dose increases by 4; For pts. with CPG > 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG > 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG > 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG <60 mg/dl, NPH initiation: 0, ½ of previous dose.
Standard of care	No intervention	–Patients assigned in this arm will receive standard of care following their kidney transplantation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult patients (> 18 years) with end stage renal disease (ESRD) undergoing kidney transplantation;
Standard triple immunosuppressive medications following kidney transplantation including tacrolimus, mycophenolate mofetil and corticosteroids;
Capable to understand the study protocol and to give informed consent;

Key exclusion criteria (1 listed)

1. Type 1 and 2 Diabetes Mellitus (DM) either as co-morbidity or cause of ESRD;

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 treatment for hyperglycemia	Drug	Insulin treatment for hyperglycemia

Primary outcome

The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation
Time frame: 12 months
NODAT will be defined according to American Diabetes Association definition: 1. Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or 2. 2 hours Oral Glucose Tolerance Test (OGTT) values equal or greater than 200 mg/dl; and/or 3. Glycosylated hemoglobin A1c equal or greater than 6.5; and/or 4. On oral hypoglycemic agents and/or insulin therapy; Incidence is measured in terms of number of participants who meet any of these 4 criteria.

1 secondary outcome

The Incidence of New Onset of Diabetes After Transplant (NODAT) 24 Months After Kidney Transplantation
Time frame: 24 months

Results and safety

Results posted to the registry on 20 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Treatment for Hyperglycemia	18	18
Standard of Care	18	18

Primary outcome: The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Insulin Treatment for Hyperglycemia n = 18	Standard of Care n = 18
Value	3	1

Insulin Treatment for Hyperglycemia vs Standard of Care: Odds Ratio (OR): 1.03 (95% CI 1.01 to 1.06), p = 0.87, Chi-squared

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Treatment for Hyperglycemia	15 of 18 (83.3%)	15 of 18 (83.3%)	0 of 18
Standard of Care	10 of 18 (55.6%)	14 of 18 (77.8%)	0 of 18

Limitations and caveats (from the sponsor): The original trial design was to include 250 participants. Data from the Austrian site has not been provided to the PI, thus limiting the analysis to a much smaller population.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Akinlolu Ojo, MD principal investigator

University of Michigan

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 treatment for hyperglycemia in people with Prevention of New Onset Diabetes Among Kidney Transplant Patients, run by University of Michigan 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 20 Mar 2019. 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 20 Mar 2019). 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?

The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01683331.

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 20 Mar 2019.