52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
This study has been completed.
Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00575588
First received: December 14, 2007
Last updated: March 20, 2012
Last verified: March 2012
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| Tracking Information | ||||||||||
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| First Received Date ICMJE | December 14, 2007 | |||||||||
| Last Updated Date | March 20, 2012 | |||||||||
| Start Date ICMJE | December 2007 | |||||||||
| 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 ] [ Designated as safety issue: No ] 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 | Complete list of historical versions of study NCT00575588 on ClinicalTrials.gov Archive Site | |||||||||
| 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 Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | 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 | Phase 3 | |||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Type 2 Diabetes | |||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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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 | |||||||||
| Enrollment ICMJE | 891 | |||||||||
| Completion Date | August 2010 | |||||||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | |||||||||
| Ages | 18 Years and older (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | 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 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| Plan to Share Data | Not Provided | |||||||||
| IPD Description | Not Provided | |||||||||
| Responsible Party | AstraZeneca | |||||||||
| Study Sponsor ICMJE | AstraZeneca | |||||||||
| Collaborators ICMJE | Bristol-Myers Squibb | |||||||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | |||||||||
| Verification Date | March 2012 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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