Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)
NCT ID: NCT00308139
Last Updated: 2015-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
303 participants
INTERVENTIONAL
2006-04-30
2014-08-31
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
NONE
Study Groups
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Exenatide Once Weekly
Subcutaneous injection (SC), once a week of long acting release (LAR) exenatide.
exenatide, long acting release
Exenatide Twice Daily
subcutaneous injection (SC), twice a day for the first 30 weeks, followed by exenatide LAR SC injection weekly for the remainder of the study.
Sub-study: Exenatide 2 mg subcutaneous injection, Administered Using the Exenatide Once Weekly Single-Dose Tray , once a week for 11 visits, switch to Exenatide 2 mg subcutaneous injection, Administered Using the Dual chamber pen device. Exenatide 2mg SC injection administered using the Dual chamber pen device.
exenatide
Interventions
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exenatide, long acting release
exenatide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
* Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
* (For sub-study) Currently participating in open ended assessment period of main study 2993 LAR105
Exclusion Criteria
* Received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.
* Has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:
* Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
* Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
* Regular use (\> 14 days) of drugs that directly affect gastrointestinal motility;
* Regular use (\> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption;
* Regular use (\> 14 days) of medications with addictive potential such as opiates and opioids;
* Prescription or over-the-counter weight loss medications within 6 months of screening.
* (For sub-study) Subjects will be terminated from study who do not participate in the dual chamber pen substudy
16 Years
ALL
No
Sponsors
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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 182
Encino, California, United States
Research Site 171
La Jolla, California, United States
Research Site 518
San Diego, California, United States
Research Site 024
Walnut Creek, California, United States
Research Site
Colorado Springs, Colorado, United States
Research Site 057
Miami, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site 149
Indianapolis, Indiana, United States
Research Site 099
Lexington, Kentucky, United States
Research Site 017
Detroit, Michigan, United States
Research Site 224
Minneapolis, Minnesota, United States
Research Site 312
St Louis, Missouri, United States
Research Site 023
Butte, Montana, United States
Research Site 053
Rochester, New York, United States
Research Site 002
Durham, North Carolina, United States
Research Site 123
Winston-Salem, North Carolina, United States
Research Site 405
Cincinnati, Ohio, United States
Research Site 557
Marion, Ohio, United States
Research Site 231
Portland, Oregon, United States
Research Site 152
Philadelphia, Pennsylvania, United States
Research Site 587
Greer, South Carolina, United States
Research Site 015
Dallas, Texas, United States
Research Site 009
San Antonio, Texas, United States
Research Site 108
Olympia, Washington, United States
Research Site
Toronto, Ontario, Canada
Countries
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References
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Philis-Tsimikas A, Wysham CH, Hardy E, Han J, Iqbal N. Efficacy and tolerability of exenatide once weekly over 7 years in patients with type 2 diabetes: An open-label extension of the DURATION-1 study. J Diabetes Complications. 2019 Mar;33(3):223-230. doi: 10.1016/j.jdiacomp.2018.11.012. Epub 2018 Dec 5.
Henry RR, Klein EJ, Han J, Iqbal N. Efficacy and Tolerability of Exenatide Once Weekly Over 6 Years in Patients with Type 2 Diabetes: An Uncontrolled Open-Label Extension of the DURATION-1 Study. Diabetes Technol Ther. 2016 Nov;18(11):677-686. doi: 10.1089/dia.2016.0107. Epub 2016 Aug 15.
Wysham CH, MacConell LA, Maggs DG, Zhou M, Griffin PS, Trautmann ME. Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial. Mayo Clin Proc. 2015 Mar;90(3):356-65. doi: 10.1016/j.mayocp.2015.01.008.
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.
Macconell L, Pencek R, Li Y, Maggs D, Porter L. Exenatide once weekly: sustained improvement in glycemic control and cardiometabolic measures through 3 years. Diabetes Metab Syndr Obes. 2013;6:31-41. doi: 10.2147/DMSO.S35801. Epub 2013 Jan 21.
Chiquette E, Toth PP, Ramirez G, Cobble M, Chilton R. Treatment with exenatide once weekly or twice daily for 30 weeks is associated with changes in several cardiovascular risk markers. Vasc Health Risk Manag. 2012;8:621-9. doi: 10.2147/VHRM.S37969. Epub 2012 Nov 12.
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.
Taylor K, Gurney K, Han J, Pencek R, Walsh B, Trautmann M. Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years. BMC Endocr Disord. 2011 Apr 29;11:9. doi: 10.1186/1472-6823-11-9.
Buse JB, Drucker DJ, Taylor KL, Kim T, Walsh B, Hu H, Wilhelm K, Trautmann M, Shen LZ, Porter LE; DURATION-1 Study Group. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care. 2010 Jun;33(6):1255-61. doi: 10.2337/dc09-1914. Epub 2010 Mar 9.
Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang D, Porter L; DURATION-1 Study Group. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008 Oct 4;372(9645):1240-50. doi: 10.1016/S0140-6736(08)61206-4. Epub 2008 Sep 7.
Other Identifiers
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MB001-010
Identifier Type: OTHER
Identifier Source: secondary_id
2993LAR-105 (DURATION - 1)
Identifier Type: -
Identifier Source: org_study_id
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