Phase 3 · Exenatide

DURATION-NEO-2 trial results

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

Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 (percentage of total hemoglobin), Baseline to Week 28. Experimental: Exenatide: -1.13; Active Comparator: Sitagliptin: -0.75; Placebo Comparator: Placebo: -0.40.

Participants: 365
Status: completed
Completed: 2014-04
Sponsor: AstraZeneca

As posted on ClinicalTrials.gov (NCT01652729), updated at source Aug 20, 2015. 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-2 measured first

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

Experimental: Exenatiden=181	Active Comparator: Sitagliptinn=122	Placebo Comparator: Placebon=61
-1.13(0.1093)	-0.75(0.1324)	-0.40(0.1945)

Side effects by arm

Side effects in DURATION-NEO-2

Percent of participants affected. The most common events the registry lists.

Event	Experimental: Exenatide	Active Comparator: Sitagliptin	Placebo Comparator: Placebo
Any serious event	2.8%	0%	3.3%
Nausea	8.8%	1.6%	0%
Injection Site Nodule	7.7%	0%	0%
Nasopharyngitis	0.6%	0%	6.6%

Secondary outcomes

What else it measured

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

Measure	Experimental: Exenatiden=181	Active Comparator: Sitagliptinn=122	Placebo Comparator: Placebon=61
Baseline Yes	3.3	1.6	3.3
Baseline No	96.7	98.4	96.7
Week 28 Yes	43.1	32.0	24.6
Week 28 No	56.9	68.0	75.4

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

Experimental: Exenatiden=181	Active Comparator: Sitagliptinn=122	Placebo Comparator: Placebon=61
-21.3(3.864)	-11.3(4.617)	9.6(7.097)

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

Experimental: Exenatiden=181	Active Comparator: Sitagliptinn=122	Placebo Comparator: Placebon=61
-1.12(0.2592)	-1.19(0.3134)	0.15(0.4767)

Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)mg/dL · Baseline to Week 16 · least squares mean

Experimental: Exenatiden=44	Active Comparator: Sitagliptinn=31	Placebo Comparator: Placebon=15
-59.57(10.48)	-23.61(13.04)	-38.68(16.98)

The trial

How DURATION-NEO-2 was run

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus.

Exenatide once weekly suspension: Exenatide once weekly suspension 2mg subcutaneous injection
Sitagliptin 100mg: Overencapsulated Sitagliptin 100mg oral tablet once daily
Placebo: Placebo oral capsule once daily

Who could join the trial

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

Published papers

Papers from DURATION-NEO-2

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

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