Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name DURATION-NEO-1

NCTNCT01652716Other idBCB118Other idMB001-003

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 377 participants (actual)
Sponsor: AstraZeneca · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jan 2013
Primary completion: Aug 2014
Completion: Aug 2014
First posted: 30 Jul 2012 (estimated)
Last update posted: 3 Jul 2018
Conditions: Diabetes Mellitus, 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-1
NCT01652716
Jan 2013 to Aug 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 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.

Interventions

Exenatide once weekly suspensionDrug
Exenatide twice dailyDrug

Arms2

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

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
The primary objective of this study was 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.

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 \<7% at Week 28/Study Termination
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
Time frame · Baseline to Week 28
Registry description
Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination
Change in Body Weight (kg) From Baseline to Week 28
Time frame · Baseline to Week 28
Registry description
Change in body weight (kg) from baseline to Week 28/Study Termination.
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16
Time frame · Baseline to Week 16
Registry description
Change in 2-hour postprandial glucose concentrations from baseline to Week 16.

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 QWS Suspension	-1.39	0.0930
Active Comparator: Exenatide BID	-1.02	0.1147

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 QWS Suspension	3.9
Active Comparator: Exenatide BID	1.4

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 QWS Suspension	-32.7	3.906
Active Comparator: Exenatide BID	-22.5	4.917

Secondary outcomeLeast squares mean· Baseline to Week 28

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

Group	Value (kg)	Spread
Experimental: Exenatide QWS Suspension	-1.49	0.2842
Active Comparator: Exenatide BID	-1.89	0.3640

Secondary outcomeLeast squares mean· Baseline to Week 16

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

Group	Value (mg/dL)	Spread
Experimental: Exenatide QWS Suspension	-87.00	12.8374
Active Comparator: Exenatide BID	-113.74	14.8042

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Experimental: Exenatide QWS SuspensionExenatide suspension 2 mg weekly subcutaneous injection 52 weeks (28 weeks plus an additional 24 weeks)	–	12 / 229	121 / 229
Active Comparator: Exenatide BIDExenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks followed by a switch to Exenatide QWS 2mg for at least 24 weeks	–	17 / 146	94 / 146

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.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2020

7 results

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.

Wysham et al. 2020BMJ open diabetes research & carecited by 4

PMID 33037036PMC7549491DOI 10.1136/bmjdrc-2019-000773PUB-33037036

Free to read · publisher termsCC BY-NC7 results

Read at source See results (7)

Indexing hint: Clinical trial · 2018

6 results

Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes.

Wysham et al. 2018Diabetes, obesity & metabolismcited by 25

PMID 28685973PMC5724491DOI 10.1111/dom.13056PUB-28685973

Free to read · publisher termsCC BY-NC6 results

Read at source See results (6)

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 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

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