52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
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ClinicalTrials.gov Identifier: NCT00575588 |
Recruitment Status :
Completed
First Posted : December 18, 2007
Results First Posted : September 6, 2010
Last Update Posted : March 21, 2012
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Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | December 14, 2007 | |||||||||
First Posted Date ICMJE | December 18, 2007 | |||||||||
Results First Submitted Date ICMJE | August 10, 2010 | |||||||||
Results First Posted Date ICMJE | September 6, 2010 | |||||||||
Last Update Posted Date | March 21, 2012 | |||||||||
Study Start Date ICMJE | December 2007 | |||||||||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52 [ Time Frame: Baseline to 52 Weeks ] Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.
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Original Primary Outcome Measures ICMJE |
Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Safety and tolerability Other secondary measurements of glucose metabolism | |||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | 52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period | |||||||||
Official Title ICMJE | A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone. | |||||||||
Brief Summary | Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin. | |||||||||
Detailed Description | Not Provided | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 3 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Type 2 Diabetes | |||||||||
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 |
891 | |||||||||
Original Estimated Enrollment ICMJE |
838 | |||||||||
Actual Study Completion Date ICMJE | August 2010 | |||||||||
Actual Primary Completion Date | August 2009 (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 | 18 Years and older (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 | Finland, Germany, Hungary, India, Korea, Republic of, Netherlands, Norway, Russian Federation, Slovakia, United Kingdom, Vietnam | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT00575588 | |||||||||
Other Study ID Numbers ICMJE | D1680C00001 EudraCT number 2007-003998-55 |
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Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||
Responsible Party | AstraZeneca | |||||||||
Study Sponsor ICMJE | AstraZeneca | |||||||||
Collaborators ICMJE | Bristol-Myers Squibb | |||||||||
Investigators ICMJE |
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PRS Account | AstraZeneca | |||||||||
Verification Date | March 2012 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |