52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
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.
Type 2 Diabetes
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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.|
- 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.
- Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2007|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
open-label metforminDrug: Saxagliptin
Saxagliptin 5 mg tablets
Other Name: Onglyza
open-label metforminDrug: Sulphonylurea
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
Show 95 Study Locations
|Principal Investigator:||Burkhard Goke||University of Munich, Germany|
|Study Director:||Peter Ohman, MD||AstraZeneca|
|Study Chair:||Deborah Price, MSc||AstraZeneca|