Phase 2 · Exenatide

NCT03961256 trial results

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.

Progression From Prediabetes to Diabetes (Participants), 12 months after transplantation. Exenatide SR Intervention Group: 0; Standard of Care: 1.

Participants
9
Status
completed
Completed
2021-10-18
Sponsor
Mayo Clinic

As posted on ClinicalTrials.gov (NCT03961256), updated at source Oct 28, 2022. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT03961256 measured first

Progression From Prediabetes to DiabetesParticipants · 12 months after transplantation · count of participants
Exenatide SR Intervention Groupn=6Standard of Caren=3
01
Side effects by arm

Side effects in NCT03961256

Percent of participants affected, Deaths were assessed up to 20 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 12 months.. The most common events the registry lists.

EventExenatide SR Intervention Group
Any serious event0%
Diarrhea33.3%
Constipation33.3%
Erythema33.3%
Nausea16.7%
Vomiting16.7%
Dyspepsia16.7%
Abdominal pain16.7%
Secondary outcomes

What else it measured

Progression From Prediabetes to DiabetesParticipants · 24 months after transplantation · count of participants
Exenatide SR Intervention Groupn=6Standard of Caren=2
11
Creatininemg/dL · From enrollment, up to 20 months post-enrollment · median
Exenatide SR Intervention Groupn=6Standard of Caren=2
1.7(1.5 to 1.9)1.4(1.2 to 1.6)
Hemoglobin A1cpercentage of glycated hemoglobin · 12 and 24 months after kidney transplantation · median
MeasureExenatide SR Intervention Groupn=6Standard of Caren=2
12 months5.6(5.3 to 5.8)5.85(5.3 to 6.4)
24 months5.65(5.6 to 6.7)5.75(5.3 to 6.2)
Incidence of Mesangial ExpansionParticipants · 12 and 24 months after kidney transplantation · count of participants
MeasureExenatide SR Intervention Groupn=6Standard of Caren=3
12 months00
24 months00
Incidence of DeathParticipants · From enrollment, up to 20 months post-enrollment · count of participants
Exenatide SR Intervention Groupn=6
0
Graft LossParticipants · From enrollment, up to 20 months post-enrollment · count of participants
Exenatide SR Intervention Groupn=6
0
Adverse Events for Exenatide SR InterventionAdverse Events · 12 months · number
Exenatide SR Intervention Groupn=6
10
The trial

How NCT03961256 was run

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.

  • Exenatide SR Intervention Group: Subjects will receive, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.
  • Standard of Care: Subjects will receive standard post-transplant care as per Mayo Clinic usual practice.
Who could join the trial

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

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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