Phase 2
N=9
Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation
Pre Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03961256 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Progression From Prediabetes to Diabetes — 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exenatide SR (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression From Prediabetes to Diabetes |
1; 1 | — |
| SECONDARY Progression From Prediabetes to Diabetes |
1; 1 | — |
| SECONDARY Creatinine |
1.7; 1.4 | — |
| SECONDARY Hemoglobin A1c |
5.6; 5.85; 5.65; 5.75 | — |
| SECONDARY Incidence of Mesangial Expansion |
0; 0; 0; 0 | — |
| SECONDARY Incidence of Death |
— | — |
| SECONDARY Graft Loss |
— | — |
| SECONDARY Adverse Events for Exenatide SR Intervention |
10 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03961256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.