NCT03961256

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

A Phase 2, Prospective, Randomized, Multicenter, Open-Label, Controlled Trial to Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Pre Diabetes

Interventions

Type	Name	Description
DRUG	Exenatide SR	Exenatide SR 2 mg subcutaneous (SQ) weekly

Timeline

• Start date: 2019-05-09
• Primary completion: 2021-10-18
• Completion: 2021-10-18
• First posted: 2019-05-23
• Last updated: 2022-10-28
• Results posted: 2022-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study