Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-09

Study Completion Date

2021-10-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria

NCT03331289

Diabetes Mellitus, Type 2

COMPLETED PHASE4

Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure

NCT00766857

Type 2 Diabetes Mellitus Congestive Heart Failure

COMPLETED PHASE4

Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome

NCT02251431

Type 2 Diabetes Mellitus Chronic Kidney Disease Left Ventricular Diastolic Dysfunction

COMPLETED PHASE3

Effect of Exenatide on 24h-UAER in Patients With Diabetic Nephropathy

NCT02690883

Diabetic Nephropathies

COMPLETED PHASE4

A Study to Look at the Effect MEDI0382 Has on Blood Sugar in People With Type 2 Diabetes and Kidney Problems and Also to Check That MEDI0382 is Well Tolerated

NCT03550378

Type II Diabetes Mellitus Renal Insufficiency

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pre Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exenatide SR Intervention Group

Subjects will receive, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.

Group Type EXPERIMENTAL

Exenatide SR

Intervention Type DRUG

Exenatide SR 2 mg subcutaneous (SQ) weekly

Standard of Care

Subjects will receive standard post-transplant care as per Mayo Clinic usual practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exenatide SR

Exenatide SR 2 mg subcutaneous (SQ) weekly

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No