Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/17/2018 |
| Start Date: | September 2013 |
| End Date: | December 2019 |
| Contact: | Rowena Delos Santos, MD |
| Email: | delossantos@wustl.edu |
| Phone: | 314.362.4547 |
A Single Center, Randomized, Double-blind Controlled Trial of Sitagliptin Versus Placebo to Reduce the Incidence and Severity of New-onset Diabetes After Kidney Transplant
The purpose of this study is to determine whether sitagliptin is effective in preventing the
development of new-onset diabetes after kidney transplant (NODAT). Up to one-third of
previously non-diabetic patients develop NODAT after a kidney transplant. Corticosteroids and
calcineurin inhibitors are two commonly utilized anti-rejection medications that contribute
to diabetes development through multiple mechanisms; including decreased insulin production
by the pancreas. Sitagliptin is an oral medication that results in increased insulin
secretion. We hypothesize that administration of sitagliptin to transplant recipients
identified to be at risk for diabetes development will reduce the incidence and severity of
NODAT.
development of new-onset diabetes after kidney transplant (NODAT). Up to one-third of
previously non-diabetic patients develop NODAT after a kidney transplant. Corticosteroids and
calcineurin inhibitors are two commonly utilized anti-rejection medications that contribute
to diabetes development through multiple mechanisms; including decreased insulin production
by the pancreas. Sitagliptin is an oral medication that results in increased insulin
secretion. We hypothesize that administration of sitagliptin to transplant recipients
identified to be at risk for diabetes development will reduce the incidence and severity of
NODAT.
This will be a single-center, randomized, double-blind trial to evaluate the efficacy of
sitagliptin to prevent the development of new-onset diabetes after transplant (NODAT) in
previously non-diabetic patients with post-operative hyperglycemia following living-donor or
deceased-donor kidney transplant. In this trial, previously non-diabetic adult patients with
hyperglycemia (random blood sugar >200mg/dL) in the first 72 hours following kidney
transplant will be screened to determine eligibility based on inclusion/exclusion criteria.
Patients that meet study entry criteria will be stratified based on HbA1c (<5.7 or 5.7-6.4%)
and randomized in a 1:1 ratio to one of two treatment groups: sitagliptin versus placebo.
Fifty patients (25 per group) will be enrolled. Dosing period will be 3 months at which time
study drug will be discontinued and patients will be followed for an additional 3 month
period.
Study visits will occur at 0, 1, 3 and 6 months. A HbA1c and 2-hour oral glucose tolerance
test (OGTT) will be obtained at the 3 and 6 month study visit.
Screening period (Visit 1)
All patients presenting for living-donor or deceased donor kidney transplant will have a
medical history, medication history, vital signs, height, weight, body mass index, physical
exam, random blood sugar (BS), HbA1c and EKG done as part of routine pre-transplant protocol
at Barnes Jewish Hospital. Patients with hyperglycemia, defined as a random blood sugar ≥ 200
mg/dL, in the first 72 hours after kidney transplant will be screened to determine
eligibility for the study based on inclusion and exclusion criteria.
Randomization (Visit 2)
Patients meeting study entry criteria and consenting to study participation will be
stratified based on HbA1c (<5.7 or 5.7-6.4%) and block randomized in blocks of eight in a 1:1
ratio to sitagliptin versus placebo. Sitagliptin dose will be 100mg/day, adjusted per
creatinine clearance and tolerability. Patients will be instructed by a licensed diabetic
educator on proper measurement and recording of fasting and post-prandial blood sugars.
Subjects will be provided a log, standard glucometer and testing strips to maintain a blood
sugar log post-discharge. Visit 2 will occur within 24 hours after Visit 1.
Drug dosing period (Visits 3-4)
Sitagliptin or placebo will be continued until 3 months post-transplant, at which time study
medication will be discontinued and collected from the subject. At the 1 and 3 month visits,
vital signs, height, weight, and BMI will be obtained. A physical exam will be performed.
Blood sugar logs provided by the patient will be reviewed and adverse effects recorded. At
the 3 month visit (Visit 4), a HbA1c, 2-hour OGTT, fasting C-peptide and insulin level will
be obtained.
Follow-up (Visit 5)
At the 6 month final visit, 3 months following discontinuation of study medication, vital
signs, height, weight, BMI, HbA1c, 2-hour OGTT, fasting C-peptide and insulin level will be
obtained. A physical exam will be performed. Blood sugar logs provided by the patient will be
reviewed and adverse effects recorded.
sitagliptin to prevent the development of new-onset diabetes after transplant (NODAT) in
previously non-diabetic patients with post-operative hyperglycemia following living-donor or
deceased-donor kidney transplant. In this trial, previously non-diabetic adult patients with
hyperglycemia (random blood sugar >200mg/dL) in the first 72 hours following kidney
transplant will be screened to determine eligibility based on inclusion/exclusion criteria.
Patients that meet study entry criteria will be stratified based on HbA1c (<5.7 or 5.7-6.4%)
and randomized in a 1:1 ratio to one of two treatment groups: sitagliptin versus placebo.
Fifty patients (25 per group) will be enrolled. Dosing period will be 3 months at which time
study drug will be discontinued and patients will be followed for an additional 3 month
period.
Study visits will occur at 0, 1, 3 and 6 months. A HbA1c and 2-hour oral glucose tolerance
test (OGTT) will be obtained at the 3 and 6 month study visit.
Screening period (Visit 1)
All patients presenting for living-donor or deceased donor kidney transplant will have a
medical history, medication history, vital signs, height, weight, body mass index, physical
exam, random blood sugar (BS), HbA1c and EKG done as part of routine pre-transplant protocol
at Barnes Jewish Hospital. Patients with hyperglycemia, defined as a random blood sugar ≥ 200
mg/dL, in the first 72 hours after kidney transplant will be screened to determine
eligibility for the study based on inclusion and exclusion criteria.
Randomization (Visit 2)
Patients meeting study entry criteria and consenting to study participation will be
stratified based on HbA1c (<5.7 or 5.7-6.4%) and block randomized in blocks of eight in a 1:1
ratio to sitagliptin versus placebo. Sitagliptin dose will be 100mg/day, adjusted per
creatinine clearance and tolerability. Patients will be instructed by a licensed diabetic
educator on proper measurement and recording of fasting and post-prandial blood sugars.
Subjects will be provided a log, standard glucometer and testing strips to maintain a blood
sugar log post-discharge. Visit 2 will occur within 24 hours after Visit 1.
Drug dosing period (Visits 3-4)
Sitagliptin or placebo will be continued until 3 months post-transplant, at which time study
medication will be discontinued and collected from the subject. At the 1 and 3 month visits,
vital signs, height, weight, and BMI will be obtained. A physical exam will be performed.
Blood sugar logs provided by the patient will be reviewed and adverse effects recorded. At
the 3 month visit (Visit 4), a HbA1c, 2-hour OGTT, fasting C-peptide and insulin level will
be obtained.
Follow-up (Visit 5)
At the 6 month final visit, 3 months following discontinuation of study medication, vital
signs, height, weight, BMI, HbA1c, 2-hour OGTT, fasting C-peptide and insulin level will be
obtained. A physical exam will be performed. Blood sugar logs provided by the patient will be
reviewed and adverse effects recorded.
Inclusion Criteria:
1. Adult (≥18 yo) recipient of living-donor or deceased donor kidney transplant
2. Blood sugar ≥ 200 mg/dL in first 72 hours after transplant
3. No history of diabetes or prior treatment with insulin or oral hypoglycemic agents
Exclusion Criteria:
1. A1c of ≥6.5% measured immediately pre-transplant
2. Recipient of simultaneous kidney-pancreas, kidney-liver, kidney-heart, or kidney-lung
transplant
3. Prior non-renal solid organ transplant
We found this trial at
1
site
Saint Louis, Missouri 63110
Principal Investigator: Rowena Delos Santos, MD
Phone: 314-362-4547
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