Diabetes Type 2Phase 3DURATION-NEO-2NCT01652729

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

A Phase 3 study testing Exenatide once weekly suspension and Sitagliptin in people with Diabetes Type 2, run by AstraZeneca at 60 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 sitagliptin or placebo administered once 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 Type 2
What is being tested?: Exenatide once weekly suspension and Sitagliptin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 365 participants
Where: 60 sitesUnited States
Study dates: Feb 2013to Apr 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 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)

Who cannot join

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

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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

Trial locations and contacts

60 sites in 1 country.

City, postcode or hospital

60 sites in 1 country

United States60 sites

Research Site
Albuquerque, New Mexico, 87102
Research Site
Beverly Hills, California, 90036
Research Site
Birmingham, Alabama, 35216
Research Site
Boca Raton, Florida, 33432
Research Site
Buena Park, California, 90620
Research Site
Buffalo, New York, 14215
Research Site
Burke, Virginia, 22015
Research Site
Carrolton, Texas, 75007
Research Site
Charlotte, North Carolina, 28204
Research Site
Chattanooga, Tennessee, 37421
Research Site
Chicago, Illinois, 60607
Research Site
Chino, California, 91710
Research Site
Chula Vista, California, 91910
Research Site
Cincinnati, Ohio, 45246
Research Site
Clayton, North Carolina, 27520
Research Site
Corpus Christi, Texas, 78404
Research Site
Dallas, Texas, 75390
Research Site
Durham, North Carolina, 27710
Research Site
Encinitas, California, 92024
Research Site
Eugene, Oregon, 97404
Research Site
Evanston, Illinois, 60201
Research Site
Franklin, Ohio, 45005
Research Site
Greenbrae, California, 94904
Research Site
Greensboro, North Carolina, 27410
Research Site
Greer, South Carolina, 29651
Research Site
Hartsdale, New York, 10530
Research Site
Henderson, Nevada, 89052
Research Site
Hialeah, Florida, 33012
Research Site
Houston, Texas, 77072
Research Site
Houston, Texas, 77074
Research Site
Huntsville, Alabama, 35801
Research Site
Indianapolis, Indiana, 46254
Research Site
Katy, Texas, 77450
Research Site
Las Vegas, Nevada, 89101
Research Site
Las Vegas, Nevada, 89123
Research Site
Los Angeles, California, 90057
Research Site
Los Angeles, California, 90059
Research Site
Marion, Ohio, 43302
Research Site
Miami, Florida, 33143
Research Site
Miami, Florida, 33169
Research Site
Miami, Florida, 33183
Research Site
Mooresville, North Carolina, 28117
Research Site
North Hollywood, California, 91606
Research Site
Omaha, Nebraska, 68130
Research Site
Oxon Hill, Maryland, 20745
Research Site
Phoenix, Arizona, 85018
Research Site
Phoenix, Arizona, 85020
Research Site
Port Orange, Florida, 32127
Research Site
Portland, Oregon, 97210
Reseach Site
Rapid City, South Dakota, 57702
Research Site
Salisbury, North Carolina, 28144
Research Site
Salt Lake City, Utah, 84095
Research Site
Salt Lake City, Utah, 84107
Research Site
San Antonio, Texas, 78205
Research Site
Simpsonville, South Carolina, 29681
Research Site
Spokane, Washington, 99202
Research Site
St. Petersburg, Florida, 33709
Research Site
Walnut Creek, California, 94598
Research Site
West Hills, California, 91307
Research Site
Yukon, Oklahoma, 73099

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About this study

Official title: 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

Conditions: Diabetes Type 2
Being tested: Exenatide once weekly suspension, Sitagliptin, Placebo
Keywords: Diabetes, Type 2, exenatide, Sitagliptin
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

Exenatide once weekly suspensionDrug
SitagliptinDrug
PlaceboDrug
Placebo oral capsule once daily

Study groups in NCT01652729
Study group	Role	What they receive
Exenatide once weekly suspension	Experimental	Exenatide once weekly suspension 2mg subcutaneous injection Receives: Drug: Exenatide once weekly suspension
Sitagliptin 100mg	Active comparator	Overencapsulated Sitagliptin 100mg oral tablet once daily Receives: Drug: Sitagliptin
Placebo	Placebo comparator	Placebo oral capsule once daily Receives: Drug: Placebo

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
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.
Measured: Baseline to Week 28

Secondary outcomes (4)

Percentage of Subjects Achieving HbA1c <7% at Week 28
Percentage of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.
Measured: Baseline to Week 28
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.
Measured: Baseline to Week 28
Change in Body Weight (kg) From Baseline to Week 28
The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.
Measured: Baseline to Week 28
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)
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.
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.

Feb 2013Apr 2014

First posted30 Jul 2012 (estimated)
Study startFeb 2013
Primary completionApr 2014
Study completionApr 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 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: 365 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01652729
Sponsor's protocol ID: BCB120
Other IDs: MB001-004
Acronym: DURATION-NEO-2
Status last verified: Jul 2015
First submitted: 26 Jul 2012
Last updated: 20 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
PubMed 32306296
Gadde KM, Vetter ML, Iqbal N, Hardy E, Ohman P; DURATION-NEO-2 study investigators. 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. Diabetes Obes Metab. 2017 Jul;19(7):979-988. doi: 10.1111/dom.12908. Epub 2017 Mar 17.
PubMed 28205322

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 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01652729
Acronym / sponsor ID: DURATION-NEO-2 / BCB120
Conditions: Diabetes Type 2
Keywords: Diabetes, Type 2, exenatide, Sitagliptin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 365 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 30 Jul 2012 (estimated)
Results: Posted 23 Apr 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Exenatide once weekly suspension	Experimental	Drug: Exenatide once weekly suspensionExenatide once weekly suspension 2mg subcutaneous injection
Sitagliptin 100mg	Active comparator	Drug: SitagliptinOverencapsulated Sitagliptin 100mg oral tablet once daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo oral capsule once daily

Who may qualify

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

Key inclusion criteria (7 listed)

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

Key exclusion criteria (12 listed)

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

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 suspension	Drug	Exenatide once weekly suspension
Sitagliptin	Drug	Sitagliptin 100mg
PlaceboPlacebo oral capsule once daily	Drug	Placebo

Primary outcome

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

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 (Visit 8)
Time frame: Baseline to Week 16

Results and safety

Results posted to the registry on 23 Apr 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	182	155
Active Comparator: Sitagliptin	122	109
Placebo Comparator: Placebo	61	47

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 n = 181	Active Comparator: Sitagliptin n = 122	Placebo Comparator: Placebo n = 61
Value	-1.13 (0.1093)	-0.75 (0.1324)	-0.40 (0.1945)

Experimental: Exenatide vs Placebo Comparator: Placebo: LS Mean Difference: -0.72 (95% CI -1.15 to -0.30), p = 0.0010, mixed model for repeated measure
Experimental: Exenatide vs Active Comparator: Sitagliptin: LS Mean Difference: -0.38 (95% CI -0.70 to -0.06), p = 0.0209, mixed model for repeated measure
Active Comparator: Sitagliptin vs Placebo Comparator: Placebo: LS Mean Difference: -0.34 (95% CI -0.79 to 0.11), p = 0.1347, mixed model for repeated measure

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

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: Exenatide	5 of 181 (2.8%)	31 of 181 (17.1%)	Not reported
Active Comparator: Sitagliptin	0 of 122 (0%)	2 of 122 (1.6%)	Not reported
Placebo Comparator: Placebo	2 of 61 (3.3%)	4 of 61 (6.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32306296Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
Derived from this study: PubMed 28205322Gadde KM, Vetter ML, Iqbal N, Hardy E, Ohman P; DURATION-NEO-2 study investigators. 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. Diabetes Obes Metab. 2017 Jul;19(7):979-988. doi: 10.1111/dom.12908. Epub 2017 Mar 17.
BCB120\_SynopsisLink provided by the sponsor.

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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.

Peter Ohman study chair

AstraZeneca

60 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 Sitagliptin in people with Diabetes Type 2, run by AstraZeneca at 60 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 7 inclusion and 12 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 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 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. Some participants in this study may receive a placebo. 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 23 Apr 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 NCT01652729, 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 20 Aug 2015.