Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name DURATION-NEO-2

NCTNCT01652729Other idBCB120Other idMB001-004

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 365 participants (actual)
Sponsor: AstraZeneca · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Feb 2013
Primary completion: Apr 2014
Completion: Apr 2014
First posted: 30 Jul 2012 (estimated)
Last update posted: 20 Aug 2015 (estimated)
Conditions: Diabetes Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201320142015

Ph 3
DURATION-NEO-2
NCT01652729
Feb 2013 to Apr 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Exenatide once weekly suspensionDrug
SitagliptinDrug
PlaceboDrug

Arms3

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
Time frame · Baseline to Week 28
Registry description
Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.

Secondary outcomes(4)

Percentage of Subjects Achieving HbA1c <7% at Week 28
Time frame · Baseline to Week 28
Registry description
Percentage of subjects achieving HbA1c target values of \< 7.0% at Week 28/Study Termination.
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
Time frame · Baseline to Week 28
Registry description
The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.
Change in Body Weight (kg) From Baseline to Week 28
Time frame · Baseline to Week 28
Registry description
The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)
Time frame · Baseline to Week 16
Registry description
The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (\< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline to Week 28

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

Group	Value (percentage of total hemoglobin)	Spread
Experimental: Exenatide	-1.13	0.1093
Active Comparator: Sitagliptin	-0.75	0.1324
Placebo Comparator: Placebo	-0.40	0.1945

Secondary and other outcome results(4)

Secondary outcomeNumber· Baseline to Week 28

Percentage of Subjects Achieving HbA1c <7% at Week 28

Group	Value (percentage of subjects)
Experimental: Exenatide	3.3
Active Comparator: Sitagliptin	1.6
Placebo Comparator: Placebo	3.3

Secondary outcomeLeast squares mean· Baseline to Week 28

Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28

Group	Value (mg/dL)	Spread
Experimental: Exenatide	-21.3	3.864
Active Comparator: Sitagliptin	-11.3	4.617
Placebo Comparator: Placebo	9.6	7.097

Secondary outcomeLeast squares mean· Baseline to Week 28

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

Group	Value (kg)	Spread
Experimental: Exenatide	-1.12	0.2592
Active Comparator: Sitagliptin	-1.19	0.3134
Placebo Comparator: Placebo	0.15	0.4767

Secondary outcomeLeast squares mean· Baseline to Week 16

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

Group	Value (mg/dL)	Spread
Experimental: Exenatide	-59.57	10.48
Active Comparator: Sitagliptin	-23.61	13.04
Placebo Comparator: Placebo	-38.68	16.98

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Experimental: ExenatideExenatide once weekly suspension 2mg subcutaneous injection	–	5 / 181	31 / 181
Active Comparator: SitagliptinSitagliptin 100mg oral tablet once daily	–	0 / 122	2 / 122
Placebo Comparator: PlaceboPlacebo oral tablet once daily	–	2 / 61	4 / 61

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

PubMed tag: none · 2020

Corrected

Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.

Guja et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 6

PMID 32306296PMC7324446DOI 10.1007/s13300-020-00815-zPUB-32306296

Free to read · publisher termsCC BY-NC

Read at source Read the notice

Indexing hint: Randomized controlled trial · 2017

Corrected

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.

Gadde et al. 2017Diabetes, obesity & metabolismcited by 42

PMID 28205322PMC5485171DOI 10.1111/dom.12908PUB-28205322

Free to read · publisher termsCC BY-NC-ND

Read at source Read the notice

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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