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
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Metformin Drug: Sulphonylurea Drug: Saxagliptin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||891 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2010|
Saxagliptin 5 mg tablets
Other Name: Onglyza
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
- 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.
- Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks [ Time Frame: From Baseline to Week 52 ]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)
- Body Weight Change From Baseline to Week 52 [ Time Frame: Baseline, Week 52 (Last Observation Carried Forward) ]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.
- Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c [ Time Frame: Week 24 to Week 52 ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575588
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|Principal Investigator:||Burkhard Goke||University of Munich, Germany|
|Study Director:||Peter Ohman, MD||AstraZeneca|
|Study Chair:||Deborah Price, MSc||AstraZeneca|