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1981

TerminatedPhase 4Results posted

GLP-1 Receptor Agonist Therapy and Albuminuria in Patients With Type 2 Diabetes

Lead sponsor

University at Buffalo

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

•HbA1c ≤10%•UACR 30-300

Primary endpoint

•UACR, change

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 IDNCT03029351

Org study ID1981 GLP

Timeline

Milestones

Study start2017-01-10actual

Study first posted2017-01-24estimated

Last update posted2024-04-16actual

Results first posted2024-04-16actual

Primary completion2019-07actual (month precision)

Study completion2019-07actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 Diabetes for at least 1 year.

•Microalbuminuria for at least 6 months (UACR: 30-300 mg/g)

•Macroalbuminuria for at least 6 months (UACR: >300 mg/g)

•HbA1c of ≤10%

•Ages 18-65 years (inclusive of ages 18 and 65)

•On ARBs/ACEi for at >3months

Exclusion criteria

•Use of GLP-1 Receptor agonists or SGLT-2 inhibitors therapy in the last 3 months

•History or risk for pancreatitis (e.g., history of gallstones, alcohol abuse, and hypertriglyceridemia)

•Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 3 months

•Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver function defined as:

1. Aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN

2. Total bilirubin >2.0 mg/dL (34.2 µmol/L)

3. Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody

4. Liver function tests more than 3 times the upper limit of normal

•Renal impairment (serum eGFR <30 ml/min)

•HIV

•Inability to give informed consent

•History of gastroparesis

•History of medullary thyroid carcinoma or MEN 2 syndrome

•Alcoholism

•Hypertriglyceridemia (>500 mg/dl).

•Any other life-threatening, non-cardiac disease

•Uncontrolled hypertension (BP > 160/100 mm of Hg)

•Congestive Heart Failure class III or IV

•Use of an investigational agent or therapeutic regimen within 30 days of study

•Participation in any other concurrent clinical trial

•Pregnant or breastfeeding patients or females of childbearing age not on 2 forms of acceptable contraceptives.

Endpoints (1)

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.

Renal / kidney

1 endpoint

Primary/protocol endpoint

Change From Baseline in Urinary Albuminuria Levels

Time frame:baseline and 52 weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Posted result

Group	Value (mean), microgram/mg creatinine	95% CI
Exenatide Extended Release	-32	—
Placebo	-12	—

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.