Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus
NCT ID: NCT00935532
Last Updated: 2015-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
427 participants
INTERVENTIONAL
2009-07-31
2011-07-31
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
NONE
Study Groups
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exenatide once weekly
exenatide once weekly
subcutaneous injection, 2.0mg, once a week;
insulin glargine
insulin glargine
subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
Interventions
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exenatide once weekly
subcutaneous injection, 2.0mg, once a week;
insulin glargine
subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c between 7.1% and 11.0% inclusive
* body mass index (BMI) of \>18kg/m2 and \<35kg/m2, inclusive
* treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start
Exclusion Criteria
* Have been treated with drugs that promote weight loss within 90 days prior to study start.
* Have been treated with drugs that directly affect gastrointestinal motility for \> 21 consecutive days within 90 days prior to study start.
* Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).
* Have been treated for \>2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs
* Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.
* Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.
* Have donated blood within 30 days prior to study start.
20 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
Aomori, , Japan
Research Site
Chiba, , Japan
Research Site
Ehime, , Japan
Research Site
Fukuoka, , Japan
Research Site
Gunma, , Japan
Research Site
Hiroshima, , Japan
Research Site
Hokkaido, , Japan
Research Site
Hyōgo, , Japan
Research Site
Ibaraki, , Japan
Research Site
Kagawa, , Japan
Research Site
Kanagawa, , Japan
Research Site
Kumamoto, , Japan
Research Site
Kyoto, , Japan
Research Site
Nagano, , Japan
Research Site
Nagasaki, , Japan
Research Site
Nara, , Japan
Research Site
Osaka, , Japan
Research Site
Ōita, , Japan
Research Site
Saitama, , Japan
Research Site
Shizuoka, , Japan
Research Site
Tokyo, , Japan
Research Site
Toyama, , Japan
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.
Inagaki N, Atsumi Y, Oura T, Saito H, Imaoka T. Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open-label, parallel-group, multicenter, noninferiority study. Clin Ther. 2012 Sep;34(9):1892-908.e1. doi: 10.1016/j.clinthera.2012.07.007. Epub 2012 Aug 9.
Other Identifiers
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H8O-JE-GWBX
Identifier Type: -
Identifier Source: org_study_id
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