[Translation] A randomized, multicenter, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of canagliflozin in children and adolescents with type 2 diabetes
在血糖控制欠佳的(即血红蛋白A1c [HbA1c] ≥6.5%至≤10.5%)儿童和青少年2型糖尿病患者中,血糖控制措施包括仅采用节食和运动,或采用节食和运动+二甲双胍治疗,或节食和运动+胰岛素治疗,或节食和运动+二甲双胍和胰岛素的联合治疗,评价:1.在26周治疗后,评估卡格列净与安慰剂相比对HbA1c的作用。2.评估卡格列净的总体安全性和耐受性。
[Translation] In children and adolescents with type 2 diabetes who have inadequate glycemic control (i.e., hemoglobin A1c [HbA1c] ≥6.5% to ≤10.5%), whose glycemic control measures include diet and exercise alone, diet and exercise plus metformin, diet and exercise plus insulin, or a combination of diet and exercise plus metformin and insulin, evaluate: 1. To assess the effect of canagliflozin on HbA1c compared with placebo after 26 weeks of treatment. 2. To assess the overall safety and tolerability of canagliflozin.