DRUG
Exenatide SR
Exenatide SR 2 mg subcutaneous (SQ) weekly
Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation
Status
Completed
Phase
Phase 2
Enrollment
9
Locations
1
Results
Posted
Publications
0
Study summary
What the protocol is testing.
Researchers are trying to determine if an anti-diabetes medication, called Exenatide SR, is well tolerated in kidney transplant patients with elevated blood glucose levels, and if it's effective in preventing diabetes.
Full detailed description
New diabetes can develop after transplant and may affect a transplanted kidney's health and a recipient's overall health. Currently, patients who are pre-diabetic are encouraged to exercise and lose weight. Researchers are planning to test whether an addition of this medication will lead to better results and more effectively prevent diabetes in patients who already have high blood sugars. Exenatide SR is medication given by weekly injection. It increases insulin release in response to a meal and slows digestion. This medicine is already in use and approved by the US Food and Drug Administration (FDA) in patients with diabetes. However, it has not been approved for this indication; the FDA has allowed the use of this drug in this research study.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
May 23, 2019
Study start
May 9, 2019
Primary completion
Oct 18, 2021
Study completion
Oct 18, 2021
Results posted
Oct 28, 2022
Registry updated
Oct 28, 2022
Outcomes
What the study measures.
Primary outcomes
Progression From Prediabetes to Diabetes
Time frame · 12 months after transplantation
Number of subjects to have an increase in HbA1C or fasting blood sugar to diabetic range based on the American Diabetes Association (ADA) criteria after kidney transplantation
Secondary outcomes
Progression From Prediabetes to Diabetes
Time frame · 24 months after transplantation
Number of subjects to have an increase in HbA1C or fasting blood sugar to diabetic range based on the American Diabetes Association (ADA) criteria after kidney transplantation
Creatinine
Time frame · From enrollment, up to 20 months post-enrollment
A creatinine blood test measures the level of creatinine in the blood. Creatinine is a waste product that forms when creatine, which is found in the muscle, breaks down. Creatinine levels in the blood can provide the doctors with information about how well the kidneys are working. As measured in mg/dL units.
Hemoglobin A1c
Time frame · 12 and 24 months after kidney transplantation
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal.
Incidence of Mesangial Expansion
Time frame · 12 and 24 months after kidney transplantation
Number of subjects to experience mesangial expansion \>20%. Mesangial expansion occurs due to increased deposition of extracellular matrix proteins, for example fibronectin, into the mesangium. Accumulation of extracellular matrix proteins then occurs due to insufficient degradation by matrix metalloproteinases.
Incidence of Death
Time frame · From enrollment, up to 20 months post-enrollment
Number of subjects to experience death by any cause
Graft Loss
Time frame · From enrollment, up to 20 months post-enrollment
The number of subjects to experience graft loss. Primary graft failure is defined as no evidence of engraftment or hematological recovery of donor cells, within the first month after transplant, without evidence of disease relapse. Secondary graft failure refers to the loss of a previously functioning graft, resulting in cytopenia involving at least two blood cell lineages.
Adverse Events for Exenatide SR Intervention
Time frame · 12 months
Total number of adverse events reported by the subjects that received the Exenatide SR Intervention
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion criteria: * Recipients of solitary kidney transplants (i.e. not combined liver-kidney, pancreas-kidney etc.) * At 4 months after transplantation: Prediabetes (fasting blood glucose 100-125 mg/dl; or 2 hr glucose 140-199 or HgbA1c 5.7-6.4%) Exclusion criteria: * Diabetes pre-transplantation * Diabetes at 4 months * \<18 years of age * eGFR \<30 ml/min (estimated by MDRD equation from serum creatinine) * Active acute cellular rejection including borderline (If treated and resolved, these patients can be included) * BK nephropathy active * History of pancreatitis, pre-existing moderate-to-severe gastroparesis, liver cirrhosis or family /personal history of multiple endocrine neoplasia 2 or medullary thyroid cancer * Pregnant or breastfeeding women. Female Subject must be either: * Of non-child bearing potential: Post-menopausal (defined as at least 1 year without any menses) prior to screening , or documented surgically sterile or status post-hysterectomy * Or if childbearing potential, agree not to try and become pregnant during the study for at least 90 days after the final study drug administration. And have a negative serum or urine pregnancy test. And if heterosexually active, agree to consistently use two forms of highly effective birth control. * Hypersensitivity to Exenatide
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.