Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes
NCT ID: NCT01029886
Last Updated: 2015-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
912 participants
INTERVENTIONAL
2010-01-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
exenatide once weekly
subcutaneous injection, 2mg, once weekly
2
liraglutide
subcutaneous injection, forced titration to 1.8mg, once daily
Interventions
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exenatide once weekly
subcutaneous injection, 2mg, once weekly
liraglutide
subcutaneous injection, forced titration to 1.8mg, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer, MD
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Research Site
Buenos Aires, , Argentina
Research site
Mendoza, , Argentina
Research Site
Rosario, , Argentina
Research Site
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
Research Site
Alicante, , Spain
Research Site
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
Research Site
Taichung, , Taiwan
Research Site
Xindian, , Taiwan
Research Site
Yung-Kang, Tainan, , Taiwan
Research Site
Zhonghe, , Taiwan
Countries
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References
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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.
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.
Other Identifiers
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H8O-MC-GWDE
Identifier Type: -
Identifier Source: org_study_id
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