Efficacy and safety of saxagliptin in drug-naïve Asian patients with type 2 diabetes mellitus: a randomized controlled trial

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Abstract

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 (HbA1c) 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 HbA1c, fasting plasma glucose (FPG), post-prandial glucose area under the curve from 0 to 180 min (PPG AUC0–180), and the proportion of patients achieving HbA1c <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 HbA1c (−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 AUC0–180 (−417 versus −235 mmol · min/L; p = 0.0010). A significantly greater proportion of patients achieved a therapeutic glycaemic response (HbA1c <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.

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