CompletedPhase 2Results posted

A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes

Lead sponsor

Yale University

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 1 diabetes

Eligibility highlights

•HbA1c 6.5-9.5%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01928329

Org study ID1307012371

Timeline

Milestones

Study first posted2013-08-23estimated

Results first posted2019-10-22actual

Last update posted2020-03-19actual

Study start2013-09 (month precision)

Primary completion2018-06actual (month precision)

Study completion2019-08actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female aged 18-65 years who meets the American Diabetes Association standard T1DM criteria.

•Diagnosis of T1DM at least 2 years from Visit 0

•Insulin Requirement of ≤ 0.90 units/kg

•Absence of ketoacidosis in the past 6 months

•HbA1c of ≥ 6.5% and ≤ 9.5%

•Menstruating women must have a negative pregnancy test and be willing to avoid pregnancy during the study period

•Signed informed consent

Exclusion criteria

•Inability or unwillingness to give informed consent

•Current or prior use of immunomodulators or systemic steroids in the last 6 months that could potentially affect diabetes or immunologic status.

•Known hypersensitivity to Exenatide, Liraglutide or any product component.

•Participation in an investigational treatment trial within the last 6 weeks before enrollment.

•1 or more episodes of hypoglycemia (loss of consciousness or requiring the help of others) within the last 6 months.

•Another condition that would, in the view of the investigator, affect the safety of using Bydureon. This might include, among others a history of MEN 2, a history of medullary carcinoma of the thyroid or pancreatitis.

•Known severe renal impairment, end-stage renal disease or renal transplantation.

•Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exclusion of a history of localized basal cell carcinoma.

•Uncompensated heart failure, fluid overload, myocardial infarction or liver disease within the last 6 weeks before enrollment.

•Clinically active serious infection.

•Positive pregnancy test in menstruating women or lactating females.

•Concurrent use of Pramlinitide, other Incretin medications, or other anti-diabetes medications other than insulin.

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.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change From Baseline in HbA1c Levels

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · mmol/mol	95% CI
Exenatide (Bydureon)	-0.12	-
Placebo	0.11	-

Mean difference (final values)-0.2395% CI-0.50 - 0.03p0.0816Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in HbA1c Levels

Time frame:12 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · mmol/mol	95% CI
Exenatide (Bydureon)	0.08	-
Placebo	0.10	-

Mean difference (final values)-0.0295% CI-0.28 - 0.25p0.912Mixed Models Analysis

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Major Hypoglycemic Event Rate On Drug

Time frame:Up to 6 months

Documented hypoglycemia

event count, event

Posted result

Group	Median · events per month	95% CI
Exenatide (Bydureon)	0.67	0.00 - 13.00
Placebo	0.80	0.00 - 10.50

Z score-.801p0.423Wilcoxon (Mann-Whitney)

Secondary/protocol endpoint

Major Hypoglycemic Event Rate Off Drug

Time frame:Up to 12 months

Documented hypoglycemia

event count, event

Posted result

Group	Median · events per month	95% CI
Exenatide (Bydureon)	0.33	0.00 - 5.00
Placebo	0.50	0.00 - 13.17

Z score-1.312p0.189Wilcoxon (Mann-Whitney)

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.