Type 2 Diabetes MellitusPhase 3NCT01029886

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

A Phase 3 study testing exenatide once weekly and liraglutide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 108 sites in 21 countries.

Completed

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

Official record

Search all trials

Trial summary

No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: exenatide once weekly and liraglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 912 participants
Where: 108 sitesin 21 countries
Study dates: Jan 2010to Apr 2011
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

Diagnosed with type 2 diabetes
Have suboptimal glycemic control as evidenced by an HbA1c measurement at study start 7.1% and 11.0%, inclusive
Have a body mass index (BMI) ≤45 kg/m^2
Have been treated with lifestyle modification (diet and exercise) and with one of the following single oral antidiabetic agents (OADs) or combinations of OADs administered at maximum tolerated dose:
metformin
SU
metformin plus an SU
metformin plus pioglitazone

Who cannot join

Have any contraindication, allergy, or hypersensitivity for the study drug (exenatide once weekly or liraglutide), exenatide twice daily, the OAD(s) being used, or the excipients contained in these agents
If taking metformin and have a contraindication to metformin use
Have been treated within 8 weeks of study start with systemic glucocorticoid therapy by oral, intravenous, intra-articular, or intramuscular route
Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of study start
Have taken any of the following excluded medications for more than 1 week within the 3 months prior to study start, or have taken any of the following excluded medications within 1 month prior to study start:
Insulin

Show all 16Show fewer

Alpha-glucosidase inhibitors (e.g., Glyser® [miglitol] or Precose® [acarbose])
Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide])
Avandia® (rosiglitazone)
Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus® [vildagliptin], Onglyza™ [saxagliptin])
Symlin® (pramlintide acetate)
Have donated blood within 30 days prior to study start or have had a blood transfusion or severe blood loss within 3 months prior to study start
Have at any time, including a clinical trial, taken exenatide once weekly, exenatide twice daily, liraglutide, or any other GLP-1 receptor agonist or GLP-1 analog
Are currently enrolled in, or discontinued within the last 3 months or longer if required by local guidelines, from a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have previously been screen-failed from this study for any reason
If a subject discontinues metformin, sulfonylurea, or pioglitazone prior to screening, the subject can be included if they discontinued the medication (whether alone or as component of combined medication) according to a specific schedule.

Trial locations and contacts

108 sites in 21 countries.

Country

City, postcode or hospital

108 sites in 21 countries

Germany13 sites

Research Site
Bad Staffelstein
Research Site
Beckum
Research Site
Biberach
Research Site
Datteln
Research Site
Dresden
Research Site
Essen
Research Site
Ludwigshafen
Research Site
Mainz
Research Site
Meissen
Research Site
Münster
Research Site
Regensburg
Research Site
Riesa
Research Site
Stuttgart

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India10 sites

Research Site
Aligarh
Research Site
Bangalore
Research Site
Chennai
Research Site
Coimbatore
Research Site
Hyderabad
Research Site
Indore
Research Site
Karnal/Haryana
Research site
Karnataka
Research Site
Mumbai
Research Site
Pune

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Canada8 sites

Research Site
Charlottetown
Research Site
Gatineau
Research Site
Ottawa
Research Site
Sherbrooke
Research Site
Vancouver
Research Site
Victoria
Research Site
Windsor
Research Site
Winnipeg

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France7 sites

Research Site
Grenoble
Research Site
Le Creuzot
Research Site
Marseille
Research Site
Paris
Research Site
Poitiers
Research Site
Reims
Research Site
Strasbourg

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Italy7 sites

Research Site
Bari
Research Site
Cagliari
Research Site
Catanzaro
Research Site
Chieti
Research Site
Naples
Research Site
Roma
Research Site
Treviglio

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Hungary6 sites

Research Site
Békéscsaba
Research Site
Budapest
Research Site
Makó
Research Site
Mosonmagyaróvár
Research Site
Nagykanizsa
Research Site
Székesfehérvár

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Poland6 sites

Research Site
Bialystok
Research Site
Krakow
Research Site
Lodz
Research Site
Poznan
Research site
Rzeszów
Research Site
Warsaw

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Spain6 sites

Research Site
Alicante
Research Site
Alzira
Research Site
Bilbao
Research Site
Madrid
Research Site
Majadahonda
Research Site
Teruel

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Belgium5 sites

Research site
Bonheiden
Research Site
Edegem
Research Site
Genk
Research Site
Leuven
Research Site
Liège

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South Africa5 sites

Research Site
Halfway House
Research Site
Johannesburg
Research Site
Kempton Park
Research Site
Parktown
Research Site
Pretoria

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Taiwan5 sites

Research Site
Changhua
Research Site
Taichung
Research Site
Xindian
Research Site
Yung-Kang, Tainan
Research Site
Zhonghe

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Israel4 sites

Research Site
Beersheba
Research Site
Haifa
Research Site
Jerusalem
Research Site
Raanana

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Romania4 sites

Research site
Bucharest
Research site
Galati
Research site
Iași
Research site
Oradea

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Slovakia4 sites

Research Site
Bratislava
Research Site
Košice
Research Site
Malacky
Research Site
Martin

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Argentina3 sites

Research Site
Buenos Aires
Research site
Mendoza
Research Site
Rosario

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Australia3 sites

Research Site
Box Hill
Research Site
Geelong
Research Site
Keswick

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Czechia3 sites

Research Site
Brandýs nad Labem
Research Site
Prague
Research Site
Přerov

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Greece3 sites

Research Site
Athens
Research Site
Cholargós
Research Site
Pátrai

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Mexico3 sites

Research Site
Guadalajara
Research Site
México
Research Site
Monterrey

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South Korea2 sites

Research Site
Seoul
Research Site
Ulsan

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Austria1 site

Research Site
Vienna

Other trials in Austria

About this study

Official title: Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes and Inadequate Glycemic Control Treated With Lifestyle Modification and Oral Antidiabetic Medications

Conditions: Type 2 Diabetes Mellitus
Being tested: exenatide once weekly, liraglutide
Keywords: diabetes, exenatide once weekly, Byetta, liraglutide, Victoza, Amylin, Lilly
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 weeklyDrug
subcutaneous injection, 2mg, once weekly
liraglutideDrug
Also called Victoza
subcutaneous injection, forced titration to 1.8mg, once daily

Study groups in NCT01029886
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: exenatide once weekly
2	Active comparator	Not described Receives: Drug: liraglutide

What is being measured

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

Change in HbA1c From Baseline to Week 26
Change in HbA1c from baseline to the treatment endpoint at Week 26.
Measured: Baseline, Week 26

Secondary outcomes (9)

Percentage of Patients Achieving HbA1c <7.0% at Week 26
Percentage of patients achieving HbA1c <7.0% at treatment endpoint at Week 26.
Measured: Baseline, Week 26
Change in Fasting Serum Glucose From Baseline to Week 26
Change in fasting serum glucose from baseline to the treatment endpoint at Week 26.
Measured: Baseline, Week 26
Change in Body Weight From Baseline to Week 26
Change in body weight from baseline to the treatment endpoint at Week 26.
Measured: Baseline, Week 26
Change in Total Cholesterol From Baseline to Week 26
Change in total cholesterol from baseline to the treatment endpoint at Week 26.
Measured: Baseline, Week 26
Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Change in HDL-C from baseline to the treatment endpoint at Week 26.
Measured: Baseline, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline.
Measured: Baseline, Week 26
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
Change in SBP from baseline to the treatment endpoint at Week 26.
Measured: Baseline, Week 26
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26
Change in DBP from baseline to the treatment endpoint at Week 26.
Measured: Baseline, Week 26
Assessment of Event Rate of Treatment-emergent Hypoglycemic Events
Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.
Measured: Baseline to Week 26

Timeline

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

Jan 2010Apr 2011

First posted10 Dec 2009 (estimated)
Study startJan 2010
Primary completionJan 2011
Study completionApr 2011

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 Type 2 Diabetes MellitusStudies 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: 912 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01029886
Sponsor's protocol ID: H8O-MC-GWDE
Status last verified: Mar 2015
First submitted: 8 Dec 2009
Last updated: 9 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
PubMed 23748506
Buse JB, Nauck M, Forst T, Sheu WH, Shenouda SK, Heilmann CR, Hoogwerf BJ, Gao A, Boardman MK, Fineman M, Porter L, Schernthaner G. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013 Jan 12;381(9861):117-24. doi: 10.1016/S0140-6736(12)61267-7. Epub 2012 Nov 7.
PubMed 23141817

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 Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes and Inadequate Glycemic Control Treated With Lifestyle Modification and Oral Antidiabetic Medications
ClinicalTrials.gov ID: NCT01029886
Acronym / sponsor ID: H8O-MC-GWDE
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes, exenatide once weekly, Byetta, liraglutide, Victoza, Amylin, Lilly
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 912 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Jan 2010
Primary completion: Jan 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 10 Dec 2009 (estimated)
Results: Posted 21 Mar 2012

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: 2

Arm	Type	Receives
1	Experimental	Drug: exenatide once weekly
2	Active comparator	Drug: liraglutide

Who may qualify

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

Key inclusion criteria (8 listed)

Diagnosed with type 2 diabetes
Have suboptimal glycemic control as evidenced by an HbA1c measurement at study start 7.1% and 11.0%, inclusive
Have a body mass index (BMI) ≤45 kg/m^2
Have been treated with lifestyle modification (diet and exercise) and with one of the following single oral antidiabetic agents (OADs) or combinations of OADs administered at maximum tolerated dose:

Key exclusion criteria (16 listed)

Have any contraindication, allergy, or hypersensitivity for the study drug (exenatide once weekly or liraglutide), exenatide twice daily, the OAD(s) being used, or the excipients contained in these agents
If taking metformin and have a contraindication to metformin use
Have been treated within 8 weeks of study start with systemic glucocorticoid therapy by oral, intravenous, intra-articular, or intramuscular route
Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of study start
Have taken any of the following excluded medications for more than 1 week within the 3 months prior to study start, or have taken any of the following excluded medications within 1 month prior to study start:

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 weeklysubcutaneous injection, 2mg, once weekly	Drug	1
liraglutideAlso: Victozasubcutaneous injection, forced titration to 1.8mg, once daily	Drug	2

Primary outcome

Change in HbA1c From Baseline to Week 26
Time frame: Baseline, Week 26
Change in HbA1c from baseline to the treatment endpoint at Week 26.

9 secondary outcomes

Percentage of Patients Achieving HbA1c <7.0% at Week 26
Time frame: Baseline, Week 26
Change in Fasting Serum Glucose From Baseline to Week 26
Time frame: Baseline, Week 26
Change in Body Weight From Baseline to Week 26
Time frame: Baseline, Week 26
Change in Total Cholesterol From Baseline to Week 26
Time frame: Baseline, Week 26
Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Time frame: Baseline, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
Time frame: Baseline, Week 26
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
Time frame: Baseline, Week 26
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26
Time frame: Baseline, Week 26
Assessment of Event Rate of Treatment-emergent Hypoglycemic Events
Time frame: Baseline to Week 26

Results and safety

Results posted to the registry on 21 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exenatide Once Weekly	461	400
Liraglutide Once Daily	451	391

Primary outcome: Change in HbA1c From Baseline to Week 26

Time frame: Baseline, Week 26. Least squares mean (Standard Error). Unit: percentage of total hemoglobin

Measure	Exenatide Once Weekly n = 390	Liraglutide Once Daily n = 386
Value	-1.28 (0.05)	-1.48 (0.05)

Exenatide Once Weekly vs Liraglutide Once Daily: Least Squares Mean Difference: 0.21 (95% CI 0.08 to 0.33), p = 0.002, Mixed Models Analysis

Population analysed: ITT Population: all patients who were randomized and received study drug. All observed data from all scheduled visits (including early termination visits) were included in the mixed-model repeated measures (MMRM) analysis. Data collected at the early termination visits were mapped into the following scheduled visits.

9 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
Exenatide Once Weekly	13 of 461 (2.8%)	160 of 461 (34.7%)	Not reported
Liraglutide Once Daily	7 of 450 (1.6%)	212 of 450 (47.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23748506Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
Derived from this study: PubMed 23141817Buse JB, Nauck M, Forst T, Sheu WH, Shenouda SK, Heilmann CR, Hoogwerf BJ, Gao A, Boardman MK, Fineman M, Porter L, Schernthaner G. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013 Jan 12;381(9861):117-24. doi: 10.1016/S0140-6736(12)61267-7. Epub 2012 Nov 7.

Related trials for Type 2 Diabetes Mellitus

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Recruiting
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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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.

Chief Medical Officer, MD study director

Eli Lilly and Company

108 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide once weekly and liraglutide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 108 sites in 21 countries.

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 8 inclusion and 16 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 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in Germany, India, Canada, France, Italy and 16 more countries. 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 21 Mar 2012). 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 From Baseline to Week 26 (time frame: Baseline, Week 26). 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 NCT01029886, 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 9 Apr 2015.