Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.

A Phase 4 study testing Bydureon in people with Type 2 Diabetes, run by AstraZeneca at 29 sites in United States.

Completed

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

Trial summary

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Bydureon
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 239 participants
Where: 29 sitesUnited States
Study dates: Dec 2014to Aug 2015
Phase: Phase 4
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes mellitus (T2DM) treated with stable dose of metformin > or = to 1500mg/day as monotherapy for at least 8 weeks
Hemoglobin A1c (HbA1c) 7% to 10% at screening
Body mass index (BMI) < or = to 45 kg/m2

Who cannot join

History of taking antihyperglycemic therapy other than metformin or metformin extended release (XR) during the 8 weeks prior to screening
History of taking a dipeptidyl peptidase-4 (DPP-4) inhibitor or pramlintide during 12 weeks prior to screening
History of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study
History of prescription or over the counter weight loss medication during 3 months prior to screening
Previous exposure to exenatide or any glucagon-like peptide-1 (GLP-1) receptor agonist during 6 months prior to screening

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

United States29 sites

Research Site
Anaheim, California
Research Site
Burke, Virginia
Research Site
Butte, Montana
Research Site
Chicago, Illinois
Research Site
Chino, California
Research Site
Corpus Christi, Texas
Research Site
Edina, Minnesota
Research Site
Franklin, Ohio
Research Site
Hollywood, Florida
Research Site
Houston, Texas
Research Site
Katy, Texas
Research Site
Las Vegas, Nevada
Research Site
Los Angeles, California
Research Site
Manassas, Virginia
Research Site
Marietta, Georgia
Research Site
Marion, Ohio
Research Site
Miami, Florida
Research Site
Mt. Pleasant, South Carolina
Research Site
North Hollywood, California
Research Site
Oklahoma City, Oklahoma
Research Site
Olympia, Washington
Research Site
Port Orange, Florida
Research Site
Rapid City, South Dakota
Research Site
Salt Lake City, Utah
Research Site
Santa Ana, California
Research Site
Spring Valley, California
Research Site
St Louis, Missouri
Research Site
Tustin, California
Research Site
Walnut Creek, California

Other trials in United States

About this study

Official title: A Randomized Double-blind, Parallel-group Study to Evaluate the Effect of BYDUREON Compared With Placebo on 24-hour Glucose Control in Metformin-treated Patients With Type 2 Diabetes

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.

Read the detailed description

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2 Diabetes

Conditions: Type 2 Diabetes
Being tested: Bydureon, Placebo
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.

BydureonDrug
Also called exenatide
Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.
PlaceboDrug
Placebo

Study groups in NCT02288273
Study group	Role	What they receive
Bydureon	Experimental	Once weekly injected exenatide Receives: Drug: Bydureon
Placebo	Placebo comparator	Placebo comparator Receives: Drug: Placebo

What is being measured

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

Change in 24-hour Mean Weighted Glucose
Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70).
Measured: Day 27/28

Secondary outcomes (5)

Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient
Measured: Day 64/65
Change From Baseline (Day1) to Day 70 and Day 22 in FPG
Measured: Day 22/Day70
Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)
Measured: Day 22 and Day 64
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Measured: Week 4 and Week 10
Change in HbA1c From Baseline to Day 22 and Baseline to Day 70
Measured: Day 22 and Day 70

Timeline

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

Dec 2014Aug 2015

First posted11 Nov 2014 (estimated)
Study startDec 2014
Primary completionAug 2015
Study completionAug 2015

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.
Other trials for Type 2 DiabetesStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02288273
Sponsor's protocol ID: D5551L00006
Status last verified: Dec 2016
First submitted: 7 Nov 2014
Last updated: 27 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double-blind, Parallel-group Study to Evaluate the Effect of BYDUREON Compared With Placebo on 24-hour Glucose Control in Metformin-treated Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT02288273
Acronym / sponsor ID: D5551L00006
Conditions: Type 2 Diabetes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 239 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 11 Nov 2014 (estimated)
Results: Posted 27 Jan 2017

Clinical summary

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

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.

Detailed description

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2 Diabetes

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Bydureon	Experimental	Drug: BydureonOnce weekly injected exenatide
Placebo	Placebo comparator	Drug: PlaceboPlacebo comparator

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Type 2 diabetes mellitus (T2DM) treated with stable dose of metformin > or = to 1500mg/day as monotherapy for at least 8 weeks
Hemoglobin A1c (HbA1c) 7% to 10% at screening
Body mass index (BMI) < or = to 45 kg/m2

Key exclusion criteria (5 listed)

History of taking antihyperglycemic therapy other than metformin or metformin extended release (XR) during the 8 weeks prior to screening
History of taking a dipeptidyl peptidase-4 (DPP-4) inhibitor or pramlintide during 12 weeks prior to screening
History of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study
History of prescription or over the counter weight loss medication during 3 months prior to screening
Previous exposure to exenatide or any glucagon-like peptide-1 (GLP-1) receptor agonist during 6 months prior to screening

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
BydureonAlso: exenatideOnce weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.	Drug	Bydureon
PlaceboPlacebo	Drug	Placebo

Primary outcome

Change in 24-hour Mean Weighted Glucose
Time frame: Day 27/28
Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70).

5 secondary outcomes

Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient
Time frame: Day 64/65
Change From Baseline (Day1) to Day 70 and Day 22 in FPG
Time frame: Day 22/Day70
Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)
Time frame: Day 22 and Day 64
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Time frame: Week 4 and Week 10
Change in HbA1c From Baseline to Day 22 and Baseline to Day 70
Time frame: Day 22 and Day 70

Results and safety

Results posted to the registry on 27 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Once Weekly (EQW) + Met	61	53
Placebo + Met	56	48

Primary outcome: Change in 24-hour Mean Weighted Glucose

Time frame: Day 27/28. Mean (Standard Deviation). Unit: (mg/dL)

Measure	EQW + Met n = 60	Placebo + Met n = 56
Baseline (Day -1/1)	185.7 (41.99)	183.8 (42.59)
Day 27/28	158.3 (35.72)	176.9 (44.03)
Change from Baseline to Day 27/28	-26.0 (3.58)	-5.3 (3.85)
Change from Baseline to Day 69/70	-30.8 (4.54)	-3.0 (4.78)

EQW + Met vs Placebo + Met: p <0.001, Mixed Models Analysis

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 weeks. Other adverse events reported at .02% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EQW + Met	4 of 60 (6.7%)	35 of 60 (58.3%)	Not reported
Placebo + Met	1 of 56 (1.8%)	26 of 56 (46.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bydureon in people with Type 2 Diabetes, run by AstraZeneca at 29 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 3 inclusion and 5 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 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 27 Jan 2017). 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 24-hour Mean Weighted Glucose (time frame: Day 27/28). 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 NCT02288273.

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 27 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.