DURATION-NEO-2

CompletedPhase 3Results posted

Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

365

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 IDNCT01652729

Org study IDBCB120

Secondary IDMB001-004Bristol Myers Squibb

Timeline

Milestones

Study first posted2012-07-30estimated

Results first posted2015-04-23estimated

Last update posted2015-08-20estimated

Study start2013-02 (month precision)

Primary completion2014-04actual (month precision)

Study completion2014-04actual (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 of 7.1% to 11.0%, inclusive, at screening

•Has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening

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

•Body mass index of <45 kg/m2 at screening

•Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening)

Exclusion criteria

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

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

•History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 mL/min

•Active cardiovascular disease

•Presence or history of severe congestive heart failure

•Central nervous system disease, including epilepsy

•Liver disease

•History of severe gastrointestinal diseases

•Clinically significant malignant disease

•Repeated severe hypoglycemia within the last 6 months

•Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog

•Any DPP-4 inhibitor within 3 months prior screening

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	-1.12	—
Active Comparator: Sitagliptin	-1.19	—
Placebo Comparator: Placebo	0.15	—

LS Mean Difference0.0795% CI-0.73 – 0.87p0.8625mixed model for repeated measure

LS Mean Difference-1.2795% CI-2.34 – -0.20p0.0198mixed model for repeated measure

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	-1.13	—
Active Comparator: Sitagliptin	-0.75	—
Placebo Comparator: Placebo	-0.40	—

LS Mean Difference-0.7295% CI-1.15 – -0.30p0.0010mixed model for repeated measure

LS Mean Difference-0.3895% CI-0.70 – -0.06p0.0209mixed model for repeated measure

LS Mean Difference-0.3495% CI-0.79 – 0.11p0.1347mixed model for repeated measure

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: ExenatideBaseline Yes	3.3	—
Baseline No	96.7	—
Week 28 Yes	43.1	—
Week 28 No	56.9	—
Active Comparator: SitagliptinBaseline Yes	1.6	—
Baseline No	98.4	—
Week 28 Yes	32.0	—
Week 28 No	68.0	—
Placebo Comparator: PlaceboBaseline Yes	3.3	—
Baseline No	96.7	—
Week 28 Yes	24.6	—
Week 28 No	75.4	—

p0.0489Cochran-Mantel-Haenszel

Percentage of Subjects Achieving HbA1c \<7% at Week 28.

p0.0103Cochran-Mantel-Haenszel

Percentage of Subjects Achieving HbA1c \<7% at Week 28.

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	-21.3	—
Active Comparator: Sitagliptin	-11.3	—
Placebo Comparator: Placebo	9.6	—

LS Mean Difference-10.195% CI-21.8 – 1.7p0.0924mixed model for repeated measure

LS Mean Difference-30.995% CI-46.7 – -15.1p0.0001mixed model for repeated measure

Secondary/protocol endpoint

Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)

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	-59.57	—
Active Comparator: Sitagliptin	-23.61	—
Placebo Comparator: Placebo	-38.68	—

LS Mean Difference-35.9695% CI-67.23 – -4.68p0.0248general linear model

LS Mean Difference-20.8995% CI-60.02 – 18.25p0.2914general linear model

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

Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.
Diabetes therapy : research, treatment and education of diabetes and related disorders2020 Jul (month)PMID32306296doi:10.1007/s13300-020-00815-zvia clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of autoinjected exenatide once-weekly suspension versus sitagliptin or placebo with metformin in patients with type 2 diabetes: The DURATION-NEO-2 randomized clinical study.
Diabetes, obesity & metabolism2017 Jul (month)PMID28205322doi:10.1111/dom.12908via 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.