Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)
NCT ID: NCT00676338
Last Updated: 2015-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
820 participants
INTERVENTIONAL
2008-11-30
2011-01-31
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
DOUBLE
Study Groups
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Exenatide Once Weekly
exenatide once weekly
subcutaneous injection, 2mg, once weekly plus placebo oral once daily
Metformin
metformin
oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection
Sitagliptin
sitagliptin
oral, 100 mg, daily plus placebo once weekly subcutaneous injection
Pioglitazone
pioglitazone
oral, 30-45mg, daily plus placebo once weekly subcutaneous injection
Interventions
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exenatide once weekly
subcutaneous injection, 2mg, once weekly plus placebo oral once daily
metformin
oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection
sitagliptin
oral, 100 mg, daily plus placebo once weekly subcutaneous injection
pioglitazone
oral, 30-45mg, daily plus placebo once weekly subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* at least 18 years of age.
* HbA1c between 7.1% and 11.0%, inclusive.
* Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.
* Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening).
Exclusion Criteria
* Have a history of renal transplantation or are currently receiving renal dialysis
* Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
* Have history of severe GI disorder (e.g., gastroparesis)
* Have a history of acute or chronic pancreatitis.
* Have active proliferative retinopathy.
* 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 screening.
* Have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening.
* Have had an organ transplant.
* Have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Are currently enrolled in any other clinical study.
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
Buena Park, California, United States
Research Site
Los Angeles, California, United States
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Valencia, California, United States
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Jacksonville, Florida, United States
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Atlanta, Georgia, United States
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Meridian, Idaho, United States
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Des Moines, Iowa, United States
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Grand Rapids, Michigan, United States
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Minneapolis, Minnesota, United States
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Billings, Montana, United States
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Toms River, New Jersey, United States
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Wilmington, North Carolina, United States
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Danville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Wilke Barre, Pennsylvania, United States
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Austin, Texas, United States
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El Paso, Texas, United States
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New Branufels, Texas, United States
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Buenos Aires, , Argentina
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Mar del Plata, , Argentina
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Leuven, , Belgium
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Marchovelette, , Belgium
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Tessenderlo, , Belgium
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Brasília, , Brazil
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Campinas, , Brazil
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Curitiba, , Brazil
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Fortaleza, , Brazil
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Joinville, , Brazil
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Porto Alegre, , Brazil
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Recife, , Brazil
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São Paulo, , Brazil
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Coquitlam, British Columbia, Canada
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Penticton, British Columbia, Canada
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Ottawa, Ontario, Canada
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Gatineu, Quebec, Canada
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Mississauga, , Canada
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Petitcodiac, , Canada
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Pointe-Claire, , Canada
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Regina, , Canada
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Saint John, , Canada
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Châteaugiron, , France
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Mûrs-Erigné, , France
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Nantes, , France
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Vieux-Condé, , France
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Dresden, , Germany
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Mainz, , Germany
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Münster, , Germany
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Rodgau, , Germany
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Budapest, , Hungary
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Gyula, , Hungary
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Hódmezővásárhely, , Hungary
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Pécs, , Hungary
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Ahmedabad, , India
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Bangalore, , India
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Channai, , India
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Kochi, , India
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Mumbai, , India
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New Dehli, , India
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Pune, , India
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Holon, , Israel
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Tel Litwinsky, , Israel
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Florence, , Italy
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Milan, , Italy
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Siena, , Italy
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Lublin, , Poland
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Szczecin, , Poland
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Wroclaw, , Poland
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Manatí, , Puerto Rico
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Toa Baja, , Puerto Rico
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Galati, , Romania
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Oradea, , Romania
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Târgu Mureş, , Romania
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Arkhangelsk, , Russia
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Moscow, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Stavropol, , Russia
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Bratislava, , Slovakia
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Trebišov, , Slovakia
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Johannesburg, , South Africa
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Kempton Park, , South Africa
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Midrand, , South Africa
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Soweto, , South Africa
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Busan, , South Korea
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Daegu, , South Korea
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Jeonju, , South Korea
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Seoul, , South Korea
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Sungnam, , South Korea
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Alicante, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Seville, , Spain
Research Site
Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
Research Site
Sisli-Istanbul, , Turkey (Türkiye)
Research Site
Bath, , United Kingdom
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Birmingham, , United Kingdom
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Edinburgh, , United Kingdom
Research Site
Frome, , United Kingdom
Research Site
Guildford, , United Kingdom
Research Site
Hull, , United Kingdom
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Sheffield, , United Kingdom
Research Site
Swansea, , United Kingdom
Countries
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References
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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.
Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Postgrad Med. 2013 May;125(3):58-67. doi: 10.3810/pgm.2013.05.2661.
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.
Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.
Russell-Jones D, Cuddihy RM, Hanefeld M, Kumar A, Gonzalez JG, Chan M, Wolka AM, Boardman MK; DURATION-4 Study Group. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care. 2012 Feb;35(2):252-8. doi: 10.2337/dc11-1107. Epub 2011 Dec 30.
Other Identifiers
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H8O-MC-GWCH (DURATION - 4)
Identifier Type: -
Identifier Source: org_study_id
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