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  • Title: Adding saxagliptin to extended-release metformin vs. uptitrating metformin dosage.
    Author: Fonseca V, Zhu T, Karyekar C, Hirshberg B.
    Journal: Diabetes Obes Metab; 2012 Apr; 14(4):365-71. PubMed ID: 22192246.
    Abstract:
    AIM: To investigate whether patients taking metformin for type 2 diabetes mellitus (T2DM) have improved glycaemic control without compromising tolerability by adding an agent with a complementary mechanism of action vs. uptitrating metformin. METHODS: Adults with T2DM and glycated haemoglobin (HbA1c) between 7.0 and 10.5% receiving metformin extended release (XR) 1500 mg/day for ≥8 weeks were randomized to receive saxagliptin 5 mg added to metformin XR 1500 mg (n = 138) or metformin XR uptitrated to 2000 mg/day (n = 144). Endpoints were change from baseline to week 18 in HbA1c (primary), 120-min postprandial glucose (PPG), fasting plasma glucose (FPG) and the proportion of patients achieving HbA1c <7%. RESULTS: At week 18, the adjusted mean reduction from baseline HbA1c was -0.88% for saxagliptin + metformin XR and -0.35% for uptitrated metformin XR (difference, -0.52%; p < 0.0001). For 120-min PPG and FPG, differences in adjusted mean change from baseline between saxagliptin + metformin XR and uptitrated metformin XR were -1.3 mmol/l (-23.32 mg/dl) (p = 0.0013) and -0.73 mmol/l (-13.18 mg/dl) (p = 0.0030), respectively. More patients achieved HbA1c <7.0% with saxagliptin + metformin XR than with uptitrated metformin XR (37.2 vs. 26.1%; p = 0.0459). The proportions of patients experiencing any adverse events (AEs) were generally similar between groups; neither group showed any notable difference in hypoglycaemia or gastrointestinal AEs. CONCLUSION: Adding saxagliptin to metformin XR provided superior glycaemic control compared with uptitrating metformin XR without the emergence of additional safety concerns.
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