Phase 3 · Exenatide

DURATION-NEO-1 trial results

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

Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 (Percentage of total hemoglobin), Baseline to Week 28. Experimental: Exenatide QWS Suspension: -1.39; Active Comparator: Exenatide BID: -1.02.

Participants: 377
Status: completed
Completed: 2014-08
Sponsor: AstraZeneca

As posted on ClinicalTrials.gov (NCT01652716), updated at source Jul 3, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What DURATION-NEO-1 measured first

Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28Percentage of total hemoglobin · Baseline to Week 28 · least squares mean

Experimental: Exenatide QWS Suspensionn=229	Active Comparator: Exenatide BIDn=146
-1.39(0.0930)	-1.02(0.1147)

Side effects by arm

Side effects in DURATION-NEO-1

Percent of participants affected, up to 52 week data reported. The most common events the registry lists.

Event	Experimental: Exenatide QWS Suspension	Active Comparator: Exenatide BID
Any serious event	5.2%	11.6%
Nausea	9.6%	22.6%
Injection Site Nodule	15.7%	4.1%
Diarrhoea	6.1%	12.3%
Vomiting	3.9%	7.5%
Upper Respiratory Tract Infection	6.6%	5.5%
Headache	6.1%	6.2%
Nasopharyngitis	4.8%	6.2%

Secondary outcomes

What else it measured

Percentage of Subjects Achieving HbA1c <7% at Week 28Percentage of subjects · Baseline to Week 28 · number

Measure	Experimental: Exenatide QWS Suspensionn=229	Active Comparator: Exenatide BIDn=146
Baseline Yes	3.9	1.4
Baseline No	95.2	98.6
Week 28 Yes	49.3	43.2
Week 28 No	49.8	56.8
Baseline missing	0.9	0

Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28mg/dL · Baseline to Week 28 · least squares mean

Experimental: Exenatide QWS Suspensionn=229	Active Comparator: Exenatide BIDn=146
-32.7(3.906)	-22.5(4.917)

Change in Body Weight (kg) From Baseline to Week 28kg · Baseline to Week 28 · least squares mean

Experimental: Exenatide QWS Suspensionn=229	Active Comparator: Exenatide BIDn=146
-1.49(0.2842)	-1.89(0.3640)

Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16mg/dL · Baseline to Week 16 · least squares mean

Experimental: Exenatide QWS Suspensionn=37	Active Comparator: Exenatide BIDn=31
-87.00(12.8374)	-113.74(14.8042)

The trial

How DURATION-NEO-1 was run

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus. To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.

Exenatide once weekly suspension: Exenatide suspension 2 mg weekly subcutaneous injection
Exenatide twice daily (BID): Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks

Who could join the trial

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

Published papers

Papers from DURATION-NEO-1

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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