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Efficacy and safety of saxagliptin in drug‐naïve Asian patients with type 2 diabetes mellitus: a randomized controlled trial
Author(s) -
Pan Chang Yu,
Yang Wenying,
Tou Conrad,
GauseNilsson Ingrid,
Zhao June
Publication year - 2012
Publication title -
diabetes/metabolism research and reviews
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.307
H-Index - 110
eISSN - 1520-7560
pISSN - 1520-7552
DOI - 10.1002/dmrr.1306
Subject(s) - saxagliptin , medicine , placebo , gastroenterology , adverse effect , diabetes mellitus , area under the curve , randomized controlled trial , type 2 diabetes mellitus , type 2 diabetes , glycated haemoglobin , endocrinology , sitagliptin , pathology , alternative medicine
Background Few studies have assessed the use of new oral anti‐diabetic agents in Asian populations. This study assesses the efficacy and safety of saxagliptin versus placebo in Asian patients with type 2 diabetes mellitus (T2DM). Materials and Methods Five hundred sixty‐eight drug‐naïve adult patients with T2DM and glycated haemoglobin levels (HbA 1c ) of 7.0–10.0% (53–86 mmol/mol) were randomized 1 : 1 to receive saxagliptin 5 mg daily or placebo. Efficacy endpoints included changes from baseline to week 24 in HbA 1c , fasting plasma glucose (FPG), post‐prandial glucose area under the curve from 0 to 180 min (PPG AUC 0–180 ), and the proportion of patients achieving HbA 1c <7.0% (53 mmol/mol). Adverse events (AEs) and serious AEs (SAEs) were evaluated. Results Saxagliptin provided statistically significant adjusted mean decreases from baseline to week 24 compared with placebo, respectively, in HbA 1c (−0.84% [−9 mmol/mol] versus − 0.34% [−4 mmol/mol]; p < 0.0001), FPG (−0.90 versus −0.17 mmol/L; p < 0.0001), and PPG AUC 0–180 (−417 versus − 235 mmol · min/L; p = 0.0010). A significantly greater proportion of patients achieved a therapeutic glycaemic response (HbA 1c <7.0% [53 mmol/mol]) with saxagliptin (45.8%) versus placebo (28.8%; p < 0.0001). The proportions of patients who experienced ≥1 AE (excluding hypoglycaemia) was 43.3% for saxagliptin and 35.6% for placebo. Few patients in either treatment group experienced an SAE (2.8%, saxagliptin; 1.4%, placebo). A low proportion of patients reported hypoglycaemic events (1.8%, saxagliptin; 0.7%, placebo). Conclusions Saxagliptin improved glycaemic control and was well tolerated in drug‐naïve Asian patients with T2DM. Copyright © 2011 John Wiley & Sons, Ltd.