Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin
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ClinicalTrials.gov Identifier: NCT00082407 |
Recruitment Status :
Completed
First Posted : May 10, 2004
Results First Posted : July 31, 2013
Last Update Posted : April 7, 2015
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Sponsor:
AstraZeneca
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
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Tracking Information | ||||
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First Submitted Date ICMJE | May 6, 2004 | |||
First Posted Date ICMJE | May 10, 2004 | |||
Results First Submitted Date ICMJE | July 16, 2009 | |||
Results First Posted Date ICMJE | July 31, 2013 | |||
Last Update Posted Date | April 7, 2015 | |||
Study Start Date ICMJE | November 2003 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in Glcosylated Hemoglobin (HbA1c) [ Time Frame: baseline, week 52 ] Change in HbA1c from baseline to week 52
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Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin | |||
Official Title ICMJE | Efficacy of Exenatide (AC2993, Synthetic Exendin-4, LY2148568) Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin | |||
Brief Summary | This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus, Type 2 | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
505 | |||
Original Enrollment ICMJE |
526 | |||
Actual Study Completion Date ICMJE | July 2008 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Croatia, Germany, Greece, Italy, Netherlands, Portugal, Romania, Russian Federation, Slovenia, Spain, Taiwan, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00082407 | |||
Other Study ID Numbers ICMJE | H8O-MC-GWAD | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | AstraZeneca | |||
Study Sponsor ICMJE | AstraZeneca | |||
Collaborators ICMJE | Eli Lilly and Company | |||
Investigators ICMJE |
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PRS Account | AstraZeneca | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |