A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)
NCT ID: NCT00637273
Last Updated: 2015-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
514 participants
INTERVENTIONAL
2008-01-31
2009-07-31
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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1
exenatide once weekly
subcutaneous injection, 2.0mg, once a week
placebo tablet
oral tablet, once a day
2
sitagliptin
oral tablet, 100mg, once a day
placebo once weekly
subcutaneous injection, once a week
3
pioglitazone
oral tablet, 45mg, once a day
placebo once weekly
subcutaneous injection, once a week
Interventions
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exenatide once weekly
subcutaneous injection, 2.0mg, once a week
sitagliptin
oral tablet, 100mg, once a day
pioglitazone
oral tablet, 45mg, once a day
placebo tablet
oral tablet, once a day
placebo once weekly
subcutaneous injection, once a week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
* Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
* Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
* Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
1. Hormone replacement therapy (female subjects)
2. Oral contraceptives (female subjects)
3. Antihypertensive agents
4. Lipid-lowering agents
5. Thyroid replacement therapy
6. Antidepressant agents
7. Drugs known to affect body weight, including prescription medications (e.g. orlistat \[XENICAL®\], sibutramine \[MERIDIA®\], topiramate \[TOPAMAX®\]) and over-the-counter antiobesity agents
Exclusion Criteria
* Has donated blood within 60 days of study start or is planning to donate blood during the study
* Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
1. Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start
2. Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
3. Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
4. Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
5. Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin
* Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
* Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use
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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Lisa Porter, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Peoria, Arizona, United States
Research Site
Artesia, California, United States
Research Site
Concord, California, United States
Research Site
Encino, California, United States
Research Site
Greenbrae, California, United States
Research Site
La Mesa, California, United States
Research Site
Orange, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Whittier, California, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Coral Gables, Florida, United States
Research Site
DeLand, Florida, United States
Research Site
Melbourne, Florida, United States
Research Site
Miami, Florida, United States
Research Site
New Port Richey, Florida, United States
Research Site
Decatur, Georgia, United States
Research Site
Avon, Indiana, United States
Research Site
Wichita, Kansas, United States
Research Site
Paducah, Kentucky, United States
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Baton Rouge, Louisiana, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Oxon Hill, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Chelsea, Michigan, United States
Research Site
Ypsilanti, Michigan, United States
Research Site
Saint Louis Park, Minnesota, United States
Research Site
St Louis, Missouri, United States
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Butte, Montana, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
New Hyde Park, New York, United States
Research Site
New Windsor, New York, United States
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New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Statesville, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Athens, Ohio, United States
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Cincinnati, Ohio, United States
Research Site
Dayton, Ohio, United States
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Philadelphia, Pennsylvania, United States
Research Site
Rapid City, South Dakota, United States
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Memphis, Tennessee, United States
Research Site
Austin, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Olympia, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
Research Site
Bangalore, , India
Research Site
Indore, , India
Research Site
Karnāl, , India
Research Site
Mumbai, , India
Research Site
Pune, , India
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Zapopan, Jalisco, Mexico
Research Site
Mexico City, Mexico City, Mexico
Research Site
Cuernavaca, Morelos, Mexico
Research Site
Monterrey, NuevoLeon, Mexico
Research Site
Toluca, State of Mexico, Mexico
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.
Peyrot M, Bushnell DM, Best JH, Martin ML, Cameron A, Patrick DL. Development and validation of the self-management profile for type 2 diabetes (SMP-T2D). Health Qual Life Outcomes. 2012 Oct 5;10:125. doi: 10.1186/1477-7525-10-125.
Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
Wysham C, Bergenstal R, Malloy J, Yan P, Walsh B, Malone J, Taylor K. DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabet Med. 2011 Jun;28(6):705-14. doi: 10.1111/j.1464-5491.2011.03301.x.
Bergenstal RM, Wysham C, Macconell L, Malloy J, Walsh B, Yan P, Wilhelm K, Malone J, Porter LE; DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet. 2010 Aug 7;376(9739):431-9. doi: 10.1016/S0140-6736(10)60590-9. Epub 2010 Jun 26.
Other Identifiers
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BCB106 (DURATION - 2)
Identifier Type: -
Identifier Source: org_study_id
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