GLP-1 Peptide Atlas, by Delfa

CompletedPhase NAResults posted

Evaluation of Exenatide in Patients With Diabetic Neuropathy

A Single-center,Proof of Concept,Randomized,Controlled Parallel Group Clinical Trial of the Effects of Exenatide vs. a Long Acting Insulin Analog to Evaluate the Efficacy of Exenatide in Patients With Diabetic Neuropathy and Type 2 Diabetes

Lead sponsor

University of Michigan

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Diabetic neuropathy, Type 2 diabetes

Key I/E criterion

•HbA1c ≥7%

Primary endpoint

•Confirmed Clinical Neuropathy (CCN)

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 IDNCT00855439

Org study IDH80-US-X012

Timeline

Milestones

Study first posted2009-03-04estimated

Results first posted2015-05-12estimated

Last update posted2017-03-01actual

Study start2008-06 (month precision)

Primary completion2014-05actual (month precision)

Study completion2014-05actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Diabetic neuropathyType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes treated with one or more oral agents

•Persistent fasting glucose > 140 mg/dl or HbA1c > 7%

•Stable and maximally effective doses of one or more oral agents for 3 months

•Presence of diabetic peripheral neuropathy

•Age between 18 and 70 years

•No risk factors or other causes of neuropathy

•Willingness and capacity to sign the Institutional Review Board approved consent form and cooperate with the medical procedures for study duration

Exclusion criteria

•Nursing mothers or pregnant women

•A history of previous kidney, pancreas or cardiac transplantation

•A past history of neuropathy (independent of diabetes) or with a disease known to be associated with neuropathy (e.g., hepatitis C, end stage renal disease, lupus)

•Amputation of any part of either lower extremity for any reason or traumatic loss of any part of either lower extremity or congenital absence or severe deformity of lower extremity

•HbA1c > 10%

•Participation in an experimental medication trial within 3 months of starting the study.

•Undergoing therapy for malignant disease other than basal- or squamous cell carcinoma

•Requiring long-term glucocorticoid therapy

•Inability or unwillingness to comply with the protocol

Endpoints (4)

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.

Other clinical outcomes

4 endpoints

Primary/protocol endpoint

Confirmed Clinical Neuropathy (CCN)

Time frame:18 Months

categorical status, improvement

Posted result

Group	Value (number), participants	95% CI
Exenatide	14	—
Glargine	18	—

Secondary/protocol endpoint/low confidence

Cardiac Autonomic Neuropathy (CAN)

Time frame:18 months

change from baseline, improvement

Posted result

Group	Value (mean), unit-less measure	95% CI
Exenatide	1.1	—
Glargine	1.1	—

Secondary/protocol endpoint/low confidence

Cardiac Autonomic Neuropathy

Time frame:18 month

change from baseline, improvement

Posted result

Group	Value (mean), beats per minute	95% CI
Exenatide	70	—
Glargine	77	—

Other/protocol endpoint

Intra-epidermal Nerve Fiber Density

Time frame:12 months

change from baseline, improvement

Posted result

Group	Value (mean), nerve fibers per mm of skin	95% CI
Exenatide	2.1	—
Glargine	4.6	—

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Effects of exenatide on measures of diabetic neuropathy in subjects with type 2 diabetes: results from an 18-month proof-of-concept open-label randomized study.
Journal of diabetes and its complications2015 Nov-Dec (year)PMID26264399doi:10.1016/j.jdiacomp.2015.07.013via clinicaltrials gov reference derived + pubmed nct search

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.