GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT00566813

CompletedPhase 1, PHASE2Results posted

Islet Transplantation in Type 1 Diabetic Patients Using the Edmonton Protocol of Steroid Free Immunosuppression

Lead sponsor

University of Illinois at Chicago

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 1 diabetes

Key I/E criterion

—

Primary endpoints

•Treatment-emergent AEs (any)•Insulin Independence•HbA1c <6.5% achievement (HbA1c <6.5% achievement, Severe hypoglycemia)

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 IDNCT00566813

Org study IDIND11807-2004-0532

Timeline

Milestones

Study first posted2007-12-04estimated

Primary completion2010-07-05actual

Results first posted2018-11-19actual

Study completion2020-07-15actual

Last update posted2021-04-06actual

Study start2004-11 (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 1 diabetes > 5 years complicated by at least one of the following situations despite intensive insulin management:

–Reduced awareness of hypoglycemia at plasma glucose levels < 54 mg/dL

–Metabolic lability/instability characterized by two or more episodes of severe hypoglycemia or hospital visits for diabetic ketoacidosis over the last year

–Progressive secondary complications of diabetes:

–Retinopathy-three step progression using the ETDRS grading system or equivalent progression;

–Nephropathy- microalbuminuria rise of 50 µg/min (72 mg/24h) over three months within the past two years despite using an ACE inhibitor;

–Neuropathy-persistent gastroparesis, postural hypotension, neuropathic bowel or bladder, or severe peripheral neuropathy unresponsive to management

Exclusion criteria

•Co-existing cardiac disease:

–Myocardial infarction within past six months

–Angiographic evidence of non-correctable coronary artery disease

–Ischemia on functional cardiac exam d. Heart failure > NYHA II

•Active alcohol or substance abuse or cigarette smoking

•Psychiatric disorder: schizophrenia, bipolar disorder, or major depression that is unstable on medication

•Non-adherence to prescribed regimens

•Active infection including hepatitis C, hepatitis B, HIV

•TB by history, current infection, or under treatment for suspected TB

•History of malignancies except squamous or basal skin cancer

•Stroke within the past 6 months

•BMI > 26 kg/m2 or body weight > 70 kg at screening visit

•C-peptide response to glucagon stimulation, any C-peptide ≥ 0.3 ng/mL

•Inability to provide informed consent

•Age less than 18 or greater than 65 years

•Creatinine clearance < 85 mL/min/1.73 m2 by 24-hour urine collection

•Serum creatinine > 1.5 mg/dL

•Macroalbuminuria > 300 mg/24h

•Baseline Hb < 12 gm/dL in women, < 13 gm/dL in men

•Baseline liver function tests outside normal range

•Untreated proliferative retinopathy

•Positive pregnancy test, intent for pregnancy, male's intent to procreate, unwilling to use effective contraception, breast-feeding

•Previous transplant or PRA reactivity > 20%)

•Insulin requirement > 0.7 IU/kg/day

•HbA1C > 12%

•Hyperlipidemia

•Chronic use of steroids

•Use of coumadin or other anticoagulant (except aspirin) or PT INR > 1.5

•Addison's disease

•Allergy to radiographic contrast material

Endpoints (3)

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

Safety / tolerability / PK

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint/low confidence

Number of Participants With Insulin Independence at End of Study Participation

Time frame:End of 15 Month Study Participation/Follow-up

threshold achievement, improvement

Posted result

Group	Value (number), participants	95% CI
Islet Cells	4	—
Islet Cells + Etanercept + Exenatide	5	—

Primary/protocol endpoint

Number of Participants With HbA1c Less Than or Equal to 6.5 & Free of Severe Hypoglycemic Events

Time frame:At end of 15 month study participation

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Severe hypoglycemia

LOINC 4548-4

Posted result

Group	Value (number), participants	95% CI
Islet Cells	4	—
Islet Cells + Etanercept + Exenatide	5	—

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Number of Participants With Adverse Events Including Laboratory Abnormalities at the End of Study Participation

Time frame:15 months after the last transplant

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), participants	95% CI
Islet Cells	4	—
Islet Cells + Etanercept + Exenatide	5	—

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

Islet transplantation for brittle type 1 diabetes: the UIC protocol.
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2008 Jun (month)PMID18444920doi:10.1111/j.1600-6143.2008.02234.xvia CT.gov reference

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.