1. Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: a randomized controlled trial.
- Author
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Yang W, Pan CY, Tou C, Zhao J, and Gause-Nilsson I
- Subjects
- Adamantane adverse effects, Adamantane therapeutic use, Adult, Aged, Analysis of Variance, Asia epidemiology, Biomarkers blood, Blood Glucose drug effects, Blood Glucose metabolism, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 epidemiology, Dipeptides adverse effects, Double-Blind Method, Drug Therapy, Combination, Female, Glycated Hemoglobin metabolism, Humans, Hypoglycemic Agents adverse effects, Male, Metformin adverse effects, Middle Aged, Time Factors, Treatment Outcome, Adamantane analogs & derivatives, Asian People statistics & numerical data, Diabetes Mellitus, Type 2 drug therapy, Dipeptides therapeutic use, Hypoglycemic Agents therapeutic use, Metformin therapeutic use
- Abstract
Aim: To assess efficacy and safety of saxagliptin added to metformin versus placebo plus metformin in Asian patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin alone., Methods: Adults (HbA(1c) 7.0-10.0%, on stable metformin ≥ 1500 mg/day) were randomized 1:1 to saxagliptin 5mg daily plus metformin (n = 283) or placebo plus metformin (n = 287). The primary end point was HbA(1c) change from baseline to Week 24., Results: Saxagliptin plus metformin provided significant adjusted mean decreases versus placebo plus metformin (p ≤ 0.0052) in HbA(1c) (-0.78% versus -0.37%), fasting plasma glucose (-1.14 mmol/L versus -0.58 mmol/L), and postprandial glucose area under the curve from 0 to 180 min (-315 mmol min/L versus -160 mmol min/L). Significantly more saxagliptin-treated patients achieved a therapeutic glycemic response (HbA(1c)<7.0%) (46.5% versus 30.5%; p = 0.0001). The proportion of patients experiencing adverse events (excluding hypoglycemia) was similar for saxagliptin plus metformin (42.8%) versus placebo plus metformin (40.8%). Hypoglycemic events were reported in 1.4% of patients in each group., Conclusion: Saxagliptin added to metformin significantly improved glycemic control and was well tolerated in Asian patients with T2DM who had inadequate glycemic control with metformin and diet and lifestyle modification., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)
- Published
- 2011
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