| Title: |
24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy
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| Outcome Measures: |
Primary: Absolute Change From Baseline in HbA1c at Week 24 (DAO), Primary Objective: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24, From baseline to 24 week|Absolute Change From Baseline in HbA1c at Week 24 (DAO), The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis., From baseline to 24 week | Secondary: Proportion (%) of Patients With Any GI Adverse Events, Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients with any gastrointestinal adverse events., 24 weeks|Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c<7.0%, Secondary Objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion (%) of patients achieving a therapeutic glycemic response defined as HbA1c\<7.0%, 24 weeks|Proportion (%) of Patients Achieving HbA1c<7.0% Without GI Adverse Events, Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients achieving HbA1c\<7.0% without GI adverse events., Whole study duration|Change From Baseline in Fasting Plasma Glucose (FPG), Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24, From baseline to 24 week|Change From Baseline in 2H Postprandial Glucose (2HPPG), Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24, From baseline to 24 week|Change From Baseline in HOMA-β, Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function was estimated by the Homeostasis model assessment-β (HOMA-β), which was defined as fasting insulin (mU/mL) x 20 / (fasting glucose (mmol/mL) - 3.5, body weight at week 24, From baseline to 24 week|Change From Baseline in Body Weight, Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24, From baseline to 24 week
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