Safety and Efficacy Study of Saxagliptin Added to Insulin Alone or to Insulin Taken With Metformin
Tracking Information
Start Date ICMJE | November 2008 |
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Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: September 22, 2008) | Change in A1C level from baseline until Wk 24 (or until the last A1C measured before insulin is up-titrated) [ Time Frame: from baseline until Wk 24 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00757588 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: September 22, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Safety and Efficacy Study of Saxagliptin Added to Insulin Alone or to Insulin Taken With Metformin |
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Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control |
Brief Summary | The purpose of this study is to compare the effects of saxagliptin versus placebo as add-on therapy to insulin (or to insulin combined with metformin) in improving glycemic control (A1C) at 24 weeks. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Type 2 Diabetes |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 435 | ||||||||
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Estimated Completion Date | October 2010 | ||||||||
Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years to 78 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Canada, France, Hungary, India, Mexico, Poland, Russian Federation, South Africa, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00757588 | ||||
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Responsible Party | Study Director, Bristol-Myers Squibb | ||||
Study ID Numbers ICMJE | CV181-057, Eudract-2008-001089-10 | ||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
Collaborators ICMJE | AstraZeneca | ||||
Investigators ICMJE |
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Information Provided By | Bristol-Myers Squibb |
Source: http://clinicaltrials.gov/