DURATION-NEO-1

CompletedPhase 3Results posted

Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes

A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

377

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c 7.1-11%

Primary endpoint

•HbA1c, 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 IDNCT01652716

Org study IDBCB118

Secondary IDMB001-003Bristol Myers Squibb

Timeline

Milestones

Study first posted2012-07-30estimated

Results first posted2015-09-16estimated

Last update posted2018-07-03actual

Study start2013-01 (month precision)

Primary completion2014-08actual (month precision)

Study completion2014-08actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•At least 18 years old

•Diagnosed with type 2 diabetes mellitus

•HbA1c 7.1 to 11%, inclusive, at screening

•Fasting plasma glucose <280 mg/dL (15.5 mmol/L)

•Body mass index (BMI) <=45 kg/m2, inclusive, at screening

•Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents

Exclusion criteria

•History of pancreatitis or triglycerides >=500 mg/dL

•Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either

•Active cardiovascular disease

•Presence of congestive heart failure

•Liver disease

•History of severe gastrointestinal diseases

•Repeated severe hypoglycemia within the last 6 months

•Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog

•Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months

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

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight (kg) From Baseline to Week 28

Time frame:Baseline to Week 28

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Experimental: Exenatide QWS Suspension	-1.49	—
Active Comparator: Exenatide BID	-1.89	—

LS Mean Difference0.4095% CI-0.48 – 1.28p0.3744Cochran-Mantel-Haenszel

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28

Time frame:Baseline to Week 28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of total hemoglobin	95% CI
Experimental: Exenatide QWS Suspension	-1.39	—
Active Comparator: Exenatide BID	-1.02	—

LS Mean Difference-0.3795% CI-0.63 – -0.10p0.0072Mixed model for repeated measure (MMRM)

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c <7% at Week 28

Time frame:Baseline to Week 28

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of subjects	95% CI
Experimental: Exenatide QWS SuspensionBaseline Yes	3.9	—
Baseline No	95.2	—
Week 28 Yes	49.3	—
Week 28 No	49.8	—
Baseline missing	0.9	—
Active Comparator: Exenatide BIDBaseline Yes	1.4	—
Baseline No	98.6	—
Week 28 Yes	43.2	—
Week 28 No	56.8	—
Baseline missing	0	—

p0.2247Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28

Time frame:Baseline to Week 28

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Experimental: Exenatide QWS Suspension	-32.7	—
Active Comparator: Exenatide BID	-22.5	—

LS Mean Difference-10.295% CI-21.7 – 1.3p0.1656Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16

Time frame:Baseline to Week 16

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Experimental: Exenatide QWS Suspension	-87.00	—
Active Comparator: Exenatide BID	-113.74	—

LS Mean Difference26.7495% CI-5.16 – 58.64p0.0985Cochran-Mantel-Haenszel

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

Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study.
BMJ open diabetes research & care2020 Oct (month)PMID33037036doi:10.1136/bmjdrc-2019-000773via clinicaltrials gov reference derived + pubmed nct search
Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes.
Diabetes, obesity & metabolism2018 Jan (month)PMID28685973doi:10.1111/dom.13056via 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.