GLP-1 Peptide Atlas, by Delfa

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Active not recruitingPhase 3Results posted

Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol

Islet Transplantation in Type 1 Diabetic Patients Using the UIC Protocol, Phase 3

Lead sponsor

CellTrans Inc.

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)•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 IDNCT00679042

Org study IDIND11807-2007-0330

Timeline

Milestones

Study start2007-09-05actual

Study first posted2008-05-16estimated

Primary completion2017-07-19actual

Results first posted2021-04-06actual

Last update posted2026-04-06actual

Study completion2026-06-14estimated

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 mellitus for more than 5 years complicated by the following situations that persist despite intensive insulin management efforts:

•At least one episode of severe hypoglycemia in the past 3 years defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person, and which was associated with either a blood glucose level <50 mg/dL (2.8 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration

•Reduced awareness of hypoglycemia, defined by the absence of adequate autonomic symptoms at capillary glucose levels of <54 mg/dL (3 mmol/l) as reported by the subject

Exclusion criteria

•Co-existing cardiac disease: myocardial infarction within the past 6 months, angiographic evidence of non-correctable coronary artery disease, ischemia on functional cardiac exam, heart failure

•Active alcohol or substance abuse, including cigarette smoking (must be abstinent for six months)

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

•History of 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

•Family history of MEN2 or MCT

•Stroke within the past 6 months

•BMI >27 kg/m2

•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 75 years

•Creatinine clearance <80 mL/min/1.73 m2 by 24-hour urine collection

•Serum creatinine consistently >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 >80%

•Insulin requirement >0.7 IU/kg/day

•HbA1c >12%

•Hyperlipidemia (fasting cholesterol >130 mg/dL or fasting triglycerides >200 mg/dL

•Medical condition requiring chronic use of steroids

•Use of Coumadin or other antiplatelet or anticoagulant therapy, or PT-INR >1.5

•Factor V deficiency

•Smoking tobacco

•Addison's disease

•Allergy to radiographic contrast material

•Symptomatic cholecystolithiasis

•Acute or chronic pancreatitis

•Symptomatic peptic ulcer disease

•Severe unremitting diarrhea, vomiting, or other gastrointestinal disorders that could interfere with medication absorption

•Treatment with antidiabetic medication other than insulin within 4 weeks of enrollment

•Use of any study medication within 4 weeks of enrollment

•Received live attenuated vaccine(s) within 2 months of enrollment

•Any medical condition that, in the opinion of the investigator, might interfere with safe participation

Endpoints (5)

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

Safety / tolerability / PK

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Number of Subjects Reaching the Efficacy Goal

Time frame:One year after islet transplant

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Severe hypoglycemia

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
TreatmentSuccess at 1 yr post first transplant	8	—
Success at 1 yr post last transplant	11	—

Secondary/protocol endpoint/low confidence

Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant

Time frame:1 year after islet infusion

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
TreatmentFirst Tx Day 365 Absence of exogenous insulin	10	—
Last Tx Day 365 Absence of exogenous insulin	12	—
First Tx Day 365 Fasting capillary glucose in a week not exceeding 140 mg/dL more than 3X	7	—
Last Tx Day 365 Fasting capillary glucose in a week not exceeding 140 mg/dL more than 3X	4	—
First Tx Day 365 Fasting plasma glucose ≤126 mg/dL	10	—
Last Tx Day 365 Fasting plasma glucose ≤126 mg/dL	11	—
First Tx Day 365 Post-prandial capillary glucose in a week: Not exceeding 180 mg/dL more than 1X/7X	5	—
Last Tx Day 365 Post-prandial capillary glucose in a week: Not exceeding 180 mg/dL more than 1X/7X	3	—
First Tx Day 365 C-peptide (fasting or stimulated) ≥0.5 ng/mL	10	—
Last Tx Day 365 C-peptide (fasting or stimulated) ≥0.5 ng/mL	10	—

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Treatment Emergent Adverse Events

Time frame:From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
TreatmentTEAE	21	—
Serious TEAE	11	—
TEAEs rated as severe or beyond	16	—
TEAEs leading to death or discontinuation	0	—

Secondary/protocol endpoint

Hypoglycemic Episodes by HYPO Score

Time frame:One year after the last transplant

descriptive, event

Posted result

Group	Value (median), score on a scale	95% CI
TreatmentBaseline (pre-Tx)	266	2 – 1638
First Tx Day 365	40.6	0 – 1234
Last Tx Day 365	18.7	0 – 1234

Secondary/protocol endpoint

Reduction in Hypoglycemic Severity Measured by %Reduction in HYPO Score

Time frame:One year after the first and last transplant

percent change from baseline, improvement

Posted result

Group	Value (mean), percentage of HYPO baseline	95% CI
Treatment% Reduction from baseline to first tx day 365	66.1	-300 – 100
% Reduction from baseline to last tx day 365	90.1	-106 – 100

Publications (2)

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

Identifying Promising Immunomodulators for Type 1 Diabetes (T1D) and Islet Transplantation.
Journal of diabetes research2024 (year)PMID39735417doi:10.1155/jdr/5151171via clinicaltrials gov reference derived + pubmed nct search
Concerns and hopes of patients with type 1 diabetes prior to islet cell transplantation: A content analysis.
Journal of diabetes and its complications2018 Jul (month)PMID29779835doi:10.1016/j.jdiacomp.2018.04.002via 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.