Diabetes Mellitus, Type 2Phase 3DURATION-NEO-1NCT01652716

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

A Phase 3 study testing Exenatide once weekly suspension and Exenatide twice daily in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 58 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Exenatide once weekly suspension and Exenatide twice daily
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 377 participants
Where: 58 sitesUnited States
Study dates: Jan 2013to Aug 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

58 sites in 1 country.

City, postcode or hospital

58 sites in 1 country

United States58 sites

Research Site
Butte, Montana, 59701
Research Site
Charleston, South Carolina, 29407
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Chicago, Illinois, 60607
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Chicago, Illinois, 60616
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Cincinnati, Ohio, 45219
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Cincinnati, Ohio, 45227
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Columbia, Maryland, 21045
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Columbus, Ohio, 43213
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Coral Gables, Florida, 33134
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Dallas, Texas, 75230
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DeLand, Florida, 32720
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Denver, Colorado, 80220
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Detroit, Michigan, 48202
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Edina, Minnesota, 55435
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Elkridge, Maryland, 21075
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Endwell, New York, 13760
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Escondido, California, 92026
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Garden Grove, California, 92844
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Greensboro, North Carolina, 27408
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Harleysville, Pennsylvania, 19438
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Henderson, Nevada, 89052
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Houston, Texas, 77062
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Hyattsville, Maryland, 20782
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Kissimmee, Florida, 34741
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Lake Charles, Louisiana, 70601
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Lexington, Kentucky, 40503
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Little Rock, Arkansas, 72205
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Lomita, California, 90717
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Los Angeles, California, 90015
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Manassas, Virginia, 20110
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Mesa, Arizona, 85206
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Miami, Florida, 33156
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Mt. Pleasant, South Carolina, 29464
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Murray, Utah, 84123
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Muscle Shoals, Alabama, 35662
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New Bedford, Massachusetts, 02740
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New Windsor, New York, 12553
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Norfolk, Virginia, 23502
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Oklahoma City, Oklahoma, 73103
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Oklahoma City, Oklahoma, 73112
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Olympia, Washington, 98502
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Orlando, Florida, 32806
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Oviedo, Florida, 32765
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Paducah, Kentucky, 42003
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Palm Harbor, Florida, 34684
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Phoenix, Arizona, 85020
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Ponte Vedra, Florida, 32081
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Port Gibson, Mississippi, 39150
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Portland, Oregon, 97239
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Richmond, Virginia, 23294
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Salt Lake City, Utah, 84107
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San Antonio, Texas, 78205
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Santa Ana, California, 92705
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Spokane, Washington, 99202
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Spring Valley, California, 91978
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St Louis, Missouri, 63128
Research Site
Troy, Michigan, 48098
Research Site
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: 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

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.

Conditions: Diabetes Mellitus, Type 2
Being tested: Exenatide once weekly suspension, Exenatide twice daily
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exenatide once weekly suspensionDrug
Exenatide suspension 2 mg weekly subcutaneous injection
Exenatide twice dailyDrug
Also called Byetta
5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks

Study groups in NCT01652716
Study group	Role	What they receive
Exenatide once weekly suspension	Experimental	Exenatide suspension 2 mg weekly subcutaneous injection Receives: Drug: Exenatide once weekly suspension
Exenatide twice daily (BID)	Active comparator	Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks Receives: Drug: Exenatide twice daily

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

Percentage of Subjects Achieving HbA1c <7% at Week 28
Percentage of subjects achieving HbA1c <7% at Week 28/Study Termination
Measured: Baseline to Week 28
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination
Measured: Baseline to Week 28
Change in Body Weight (kg) From Baseline to Week 28
Change in body weight (kg) from baseline to Week 28/Study Termination.
Measured: Baseline to Week 28
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16
Change in 2-hour postprandial glucose concentrations from baseline to Week 16.
Measured: Baseline to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Aug 2014

First posted30 Jul 2012 (estimated)
Study startJan 2013
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 377 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01652716
Sponsor's protocol ID: BCB118
Other IDs: MB001-003
Acronym: DURATION-NEO-1
Status last verified: May 2018
First submitted: 26 Jul 2012
Last updated: 3 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wysham CH, Rosenstock J, Vetter ML, Wang H, Hardy E, Iqbal N. 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. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e000773. doi: 10.1136/bmjdrc-2019-000773.
PubMed 33037036
Wysham CH, Rosenstock J, Vetter ML, Dong F, Ohman P, Iqbal N. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):165-172. doi: 10.1111/dom.13056. Epub 2017 Aug 22.
PubMed 28685973

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01652716
Acronym / sponsor ID: DURATION-NEO-1 / BCB118
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 377 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 30 Jul 2012 (estimated)
Results: Posted 16 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Exenatide once weekly suspension	Experimental	Drug: Exenatide once weekly suspensionExenatide suspension 2 mg weekly subcutaneous injection
Exenatide twice daily (BID)	Active comparator	Drug: Exenatide twice dailyExenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exenatide once weekly suspensionExenatide suspension 2 mg weekly subcutaneous injection	Drug	Exenatide once weekly suspension
Exenatide twice dailyAlso: Byetta5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks	Drug	Exenatide twice daily (BID)

Primary outcome

Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
Time frame: Baseline to Week 28
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.

4 secondary outcomes

Percentage of Subjects Achieving HbA1c <7% at Week 28
Time frame: Baseline to Week 28
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
Time frame: Baseline to Week 28
Change in Body Weight (kg) From Baseline to Week 28
Time frame: Baseline to Week 28
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16
Time frame: Baseline to Week 16

Results and safety

Results posted to the registry on 16 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Exenatide Once Weekly (QWS) Suspension	229	173
Active Comparator: Exenatide Twice Daily (BID)	148	102

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

Time frame: Baseline to Week 28. Least squares mean (Standard Error). Unit: Percentage of total hemoglobin

Measure	Experimental: Exenatide QWS Suspension n = 229	Active Comparator: Exenatide BID n = 146
Value	-1.39 (0.0930)	-1.02 (0.1147)

Experimental: Exenatide QWS Suspension vs Active Comparator: Exenatide BID: LS Mean Difference: -0.37 (95% CI -0.63 to -0.10), p = 0.0072, Mixed model for repeated measure (MMRM)

Population analysed: Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 52 week data reported. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: Exenatide QWS Suspension	12 of 229 (5.2%)	121 of 229 (52.8%)	Not reported
Active Comparator: Exenatide BID	17 of 146 (11.6%)	94 of 146 (64.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33037036Wysham CH, Rosenstock J, Vetter ML, Wang H, Hardy E, Iqbal N. 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. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e000773. doi: 10.1136/bmjdrc-2019-000773.
Derived from this study: PubMed 28685973Wysham CH, Rosenstock J, Vetter ML, Dong F, Ohman P, Iqbal N. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):165-172. doi: 10.1111/dom.13056. Epub 2017 Aug 22.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vice President Medical Research & Development, M.D. study director

Amylin Pharmaceuticals, LLC.

58 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Exenatide once weekly suspension and Exenatide twice daily in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 (time frame: Baseline to Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01652716, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.