Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes
1 other identifier
interventional
912
20 countries
107
Brief 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. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Jan 2010
Shorter than P25 for phase_3 type-2-diabetes-mellitus
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2009
CompletedFirst Posted
Study publicly available on registry
December 10, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
March 21, 2012
CompletedApril 9, 2015
March 1, 2015
1 year
December 8, 2009
February 14, 2012
March 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c From Baseline to Week 26
Change in HbA1c from baseline to the treatment endpoint at Week 26.
Baseline, Week 26
Secondary Outcomes (9)
Percentage of Patients Achieving HbA1c <7.0% at Week 26
Baseline, Week 26
Change in Fasting Serum Glucose From Baseline to Week 26
Baseline, Week 26
Change in Body Weight From Baseline to Week 26
Baseline, Week 26
Change in Total Cholesterol From Baseline to Week 26
Baseline, Week 26
Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Baseline, Week 26
- +4 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- metformin plus an SU
- metformin plus pioglitazone
You may not qualify if:
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (108)
Research Site
Buenos Aires, Argentina
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Mendoza, Argentina
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Rosario, Argentina
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Box Hill, Australia
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Geelong, Australia
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Keswick, Australia
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Vienna, Austria
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Bonheiden, Belgium
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Edegem, Belgium
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Genk, Belgium
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Leuven, Belgium
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Liège, Belgium
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Charlottetown, Canada
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Gatineau, Canada
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Ottawa, Canada
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Sherbrooke, Canada
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Vancouver, Canada
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Victoria, Canada
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Windsor, Canada
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Winnipeg, Canada
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Brandýs nad Labem, Czechia
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Prague, Czechia
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Přerov, Czechia
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Grenoble, France
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Le Creuzot, France
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Marseille, France
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Paris, France
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Poitiers, France
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Reims, France
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Strasbourg, France
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Bad Staffelstein, Germany
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Beckum, Germany
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Biberach, Germany
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Datteln, Germany
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Dresden, Germany
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Essen, Germany
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Ludwigshafen, Germany
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Mainz, Germany
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Meissen, Germany
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Münster, Germany
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Regensburg, Germany
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Riesa, Germany
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Stuttgart, Germany
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Athens, Greece
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Cholargós, Greece
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Pátrai, Greece
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Békéscsaba, Hungary
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Budapest, Hungary
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Makó, Hungary
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Mosonmagyaróvár, Hungary
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Nagykanizsa, Hungary
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Székesfehérvár, Hungary
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Aligarh, India
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Bangalore, India
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Chennai, India
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Coimbatore, India
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Hyderabad, India
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Indore, India
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Karnal/Haryana, India
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Karnataka, India
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Mumbai, India
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Pune, India
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Beersheba, Israel
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Haifa, Israel
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Jerusalem, Israel
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Raanana, Israel
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Bari, Italy
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Cagliari, Italy
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Catanzaro, Italy
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Chieti, Italy
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Napoli, Italy
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Roma, Italy
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Treviglio, Italy
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Guadalajara, Mexico
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México, Mexico
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Monterrey, Mexico
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Bialystok, Poland
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Krakow, Poland
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Lodz, Poland
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Poznan, Poland
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Rzeszów, Poland
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Warsaw, Poland
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Bucharest, Romania
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Galati, Romania
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Iași, Romania
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Oradea, Romania
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Bratislava, Slovakia
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Košice, Slovakia
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Malacky, Slovakia
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Martin, Slovakia
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Halfway House, South Africa
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Johannesburg, South Africa
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Kempton Park, South Africa
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Parktown, South Africa
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Pretoria, South Africa
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Seoul, South Korea
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Ulsan, South Korea
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Alicante, Spain
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Alzira, Spain
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Bilbao, Spain
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Madrid, Spain
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Majadahonda, Spain
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Teruel, Spain
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Changhua, Taiwan
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Taichung, Taiwan
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Xindian, Taiwan
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Yung-Kang, Tainan, Taiwan
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Zhonghe, Taiwan
Related Publications (2)
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.
PMID: 23748506DERIVEDBuse 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.
PMID: 23141817DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Ohman, Medical Science Director
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Chief Medical Officer, MD
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2009
First Posted
December 10, 2009
Study Start
January 1, 2010
Primary Completion
January 1, 2011
Study Completion
April 1, 2011
Last Updated
April 9, 2015
Results First Posted
March 21, 2012
Record last verified: 2015-03