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Saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin with or without metformin: results from the SUPER study, a randomized, double-blind, placebo-controlled trial.

Saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin with or without metformin: results from the SUPER study, a randomized, double-blind, placebo-controlled trial.
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Chen Y, Liu X, Li Q, Ma J, Lv X, Guo L, Wang C, Shi Y, Li Y, Johnsson E, Wang M, Zhao J, Ji L,


Chen Y, Liu X, Li Q, Ma J, Lv X, Guo L, Wang C, Shi Y, Li Y, Johnsson E, Wang M, Zhao J, Ji L, (click to view)

Chen Y, Liu X, Li Q, Ma J, Lv X, Guo L, Wang C, Shi Y, Li Y, Johnsson E, Wang M, Zhao J, Ji L,

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Diabetes, obesity & metabolism 2017 11 16() doi 10.1111/dom.13161
Abstract

This prospective, multicentre, phase 3 study (NCT02104804) evaluated the efficacy and safety of saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin ± metformin. Patients with glycated haemoglobin (HbA1c) 7.5%-10.5% and fasting plasma glucose (FPG) <270 mg/dL on stable insulin therapy (20-150 U/day) were randomized (1:1) to saxagliptin 5 mg once daily (N = 232) or placebo (N = 230) for 24 weeks, stratified by metformin use. The primary efficacy measure was change in HbA1c. Saxagliptin treatment resulted in a greater adjusted mean change in HbA1c from baseline to week 24 than placebo (-0.58%; P < .001), irrespective of metformin use, and a greater mean change in FPG (-15.9 mg/dL, P < .001). More patients achieved HbA1c <7% with saxagliptin (11.4%) than with placebo (3.5%, P = .002). Adverse events and incidence of hypoglycaemia were similar in both groups. Overall, add-on saxagliptin 5 mg once daily significantly improved glycaemic control without increasing hypoglycaemia risk and was well tolerated in Chinese patients with type 2 diabetes inadequately controlled by insulin (± metformin).

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