GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

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.

Lead sponsor

Mayo Clinic

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Prediabetes / glucose intolerance, Renal impairment

Key I/E criterion

—

Primary endpoint

•Time to T2DM onset

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03961256

Org study ID19-000649

Timeline

Milestones

Study start2019-05-09actual

Study first posted2019-05-23actual

Primary completion2021-10-18actual

Study completion2021-10-18actual

Last update posted2022-10-28actual

Results first posted2022-10-28actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Prediabetes / glucose intoleranceRenal impairment

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot 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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Renal / kidney

Cardiovascular outcomes

Safety / tolerability / PK

Other clinical outcomes

Cardiovascular outcomes

1 endpoint

Secondary/protocol endpoint

Incidence of Death

Time frame:From enrollment, up to 20 months post-enrollment

All-cause death

event count, event

SNOMED 419620001

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide SR Intervention Group	0	—

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Progression From Prediabetes to Diabetes

Time frame:12 months after transplantation

Time to T2DM onset

time to event, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide SR Intervention Group	0	—
Standard of Care	1	—

Secondary/protocol endpoint

Progression From Prediabetes to Diabetes

Time frame:24 months after transplantation

Time to T2DM onset

time to event, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide SR Intervention Group	1	—
Standard of Care	1	—

Secondary/protocol endpoint

Hemoglobin A1c

Time frame:12 and 24 months after kidney transplantation

descriptive, improvement

LOINC 4548-4

Posted result

Group	Value (median), percentage of glycated hemoglobin	95% CI
Exenatide SR Intervention Group12 months	5.6	5.3 – 5.8
24 months	5.65	5.6 – 6.7
Standard of Care12 months	5.85	5.3 – 6.4
24 months	5.75	5.3 – 6.2

Renal / kidney

2 endpoints

Secondary/protocol endpoint

Creatinine

Time frame:From enrollment, up to 20 months post-enrollment

descriptive

Posted result

Group	Value (median), mg/dL	95% CI
Exenatide SR Intervention Group	1.7	1.5 – 1.9
Standard of Care	1.4	1.2 – 1.6

Secondary/protocol endpoint/low confidence

Incidence of Mesangial Expansion

Time frame:12 and 24 months after kidney transplantation

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide SR Intervention Group12 months	0	—
24 months	0	—
Standard of Care12 months	0	—
24 months	0	—

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Adverse Events for Exenatide SR Intervention

Time frame:12 months

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Adverse Events	95% CI
Exenatide SR Intervention Group	10	—

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint/low confidence

Graft Loss

Time frame:From enrollment, up to 20 months post-enrollment

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide SR Intervention Group	0	—

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.