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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
891
open-label metformin
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
Saxagliptin 5 mg tablets
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
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.
Time frame: Baseline to 52 Weeks
Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks
Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)
Time frame: From Baseline to Week 52
Body Weight Change From Baseline to Week 52
Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.
Time frame: Baseline, Week 52 (Last Observation Carried Forward)
Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c
Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.
Time frame: Week 24 to Week 52
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Research Site
Hanko, Finland
Research Site
Helsinki, Finland
Research Site
Kuopio, Finland
Research Site
Kuusankoski, Finland
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Mikkeli, Finland
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Oulu, Finland
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Tampere, Finland
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Aschaffenburg, Germany
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Berlin, Germany
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Dortmund, Germany
...and 84 more locations