title: Efficacy and safety of saxagliptin in drug-naïve Asian patients with type 2 diabetes mellitus: a randomized controlled trial.
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).
  
  
  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.
authors.affiliation: Department of Endocrinology, General Hospital of Chinese People's Liberation Army, Beijing, China. panchy301@yahoo.com.cn
authors.forename: Chang Yu
authors.initials: CY
authors.lastname: Pan
authors.forename: Wenying
authors.initials: W
authors.lastname: Yang
authors.forename: Conrad
authors.initials: C
authors.lastname: Tou
authors.forename: Ingrid
authors.initials: I
authors.lastname: Gause-Nilsson
authors.forename: June
authors.initials: J
authors.lastname: Zhao
mesh_terms: D000218:Adamantane / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D044466:Asian People; D001786:Blood Glucose / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004151:Dipeptides / Q000009:adverse effects / Q000627:therapeutic use*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010919:Placebos
chemical_list: D000218:Adamantane; D001786:Blood Glucose; D004151:Dipeptides; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D010919:Placebos; C502994:saxagliptin