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Improved glycaemic variability and time in range with dapagliflozin versus gliclazide modified release among adults with type 2 diabetes, evaluated by continuous glucose monitoring: A 12-week randomized controlled trial.
Diabetes, Obesity and Metabolism ( IF 5.4 ) Pub Date : 2019-11-10 , DOI: 10.1111/dom.13913
Andre G D Vianna 1 , Claudio S Lacerda 1 , Luciana M Pechmann 1 , Michelle G Polesel 1 , Emerson C Marino 1 , Mauro Scharf 1 , Josiane M Detsch 1 , Kleber Marques 1 , Claudia P Sanches 1
Affiliation  

AIMS To evaluate whether there is a difference between the effects of dapagliflozin and gliclazide modified release (MR) on glycaemic variability (GV) and glycaemic control, as assessed by continuous glucose monitoring (CGM), in individuals with uncontrolled type 2 diabetes. MATERIALS AND METHODS This randomized, open-label, active-controlled study was conducted in individuals with uncontrolled type 2 diabetes who were drug-naïve or on steady-dose metformin monotherapy. Participants were treated once daily with 10 mg dapagliflozin or 120 mg gliclazide MR. CGM and GV index calculations were performed at baseline and after 12 weeks. RESULTS In total, 97 participants (age 57.9 ± 8.7 years, 50.5% men, baseline glycated haemoglobin 63 ± 9.8 mmol/mol [7.9 ± 0.9%]) were randomized, and 94 completed the 12-week protocol. Intention-to-treat (ITT) and per-protocol (PP) analyses showed that the reduction in GV, as measured by the mean amplitude of glycaemic excursions, was superior in the dapagliflozin group versus the gliclazide MR group (-0.9 mmol/L [95% CI -1.5, -0.4] vs -0.2 mmol/L [95% CI -0.6, 0.3]; P = 0.030 [ITT]). The reductions in GV estimated by the coefficient of variation and SD were greater in the dapagliflozin group. Moreover, dapagliflozin increased the glucose time in range (TIR; 3.9-10 mmol/L) by 24.9% (95% CI 18.6, 31.2) vs. 17.4% (95% CI 11.6, 23.3) in the gliclazide MR group (P = 0.089 [ITT]; P = 0.041 [PP]). CONCLUSIONS Dapagliflozin improved GV and increased TIR more efficiently than gliclazide MR in individuals with type 2 diabetes over 12 weeks, as demonstrated by CGM.

中文翻译:

通过连续血糖监测评估,在 2 型糖尿病患者中使用达格列净与格列齐特缓释剂改善血糖变异性和时间范围:一项为期 12 周的随机对照试验。

目的 评估达格列净和格列齐特缓释剂 (MR) 对血糖变异性 (GV) 和血糖控制的影响是否存在差异,通过连续血糖监测 (CGM) 评估,在未控制的 2 型糖尿病患者中。材料和方法 这项随机、开放标签、主动对照研究是在未接受药物治疗或接受稳定剂量二甲双胍单药治疗的未受控制的 2 型糖尿病患者中进行的。参与者每天接受一次 10 mg 达格列净或 120 mg 格列齐特 MR 治疗。在基线和 12 周后进行 CGM 和 GV 指数计算。结果 总共有 97 名参与者(年龄 57.9 ± 8.7 岁,50.5% 男性,基线糖化血红蛋白 63 ± 9.8 mmol/mol [7.9 ± 0.9%])被随机分组​​,其中 94 人完成了为期 12 周的方案。意向治疗 (ITT) 和符合方案 (PP) 分析表明,达格列净组的 GV 降低(通过血糖波动的平均幅度测量)优于格列齐特 MR 组(-0.9 mmol/L [95% CI -1.5, -0.4] 与 -0.2 mmol/L [95% CI -0.6, 0.3];P = 0.030 [ITT])。通过变异系数和 SD 估计的 GV 降低在达格列净组中更大。此外,在格列齐特 MR 组中,达格列净将葡萄糖时间范围 (TIR; 3.9-10 mmol/L) 增加了 24.9% (95% CI 18.6, 31.2) 与 17.4% (95% CI 11.6, 23.3) (P = 0.089 [ITT];P = 0.041 [PP])。结论 如 CGM 所示,在 2 型糖尿病患者中,达格列净在 12 周内比格列齐特 MR 更有效地改善了 GV 并增加了 TIR。根据血糖波动的平均幅度测量,达格列净组优于格列齐特 MR 组(-0.9 mmol/L [95% CI -1.5, -0.4] vs -0.2 mmol/L [95% CI -0.6, 0.3];P = 0.030 [ITT])。通过变异系数和 SD 估计的 GV 降低在达格列净组中更大。此外,在格列齐特 MR 组中,达格列净将葡萄糖时间范围 (TIR; 3.9-10 mmol/L) 增加了 24.9% (95% CI 18.6, 31.2) 与 17.4% (95% CI 11.6, 23.3) (P = 0.089 [ITT];P = 0.041 [PP])。结论 如 CGM 所示,在 2 型糖尿病患者中,达格列净在 12 周内比格列齐特 MR 更有效地改善了 GV 并增加了 TIR。根据血糖波动的平均幅度测量,达格列净组优于格列齐特 MR 组(-0.9 mmol/L [95% CI -1.5, -0.4] vs -0.2 mmol/L [95% CI -0.6, 0.3];P = 0.030 [ITT])。通过变异系数和 SD 估计的 GV 降低在达格列净组中更大。此外,在格列齐特 MR 组中,达格列净将葡萄糖时间范围 (TIR; 3.9-10 mmol/L) 增加了 24.9% (95% CI 18.6, 31.2) 与 17.4% (95% CI 11.6, 23.3) (P = 0.089 [ITT];P = 0.041 [PP])。结论 如 CGM 所示,在 2 型糖尿病患者中,达格列净在 12 周内比格列齐特 MR 更有效地改善了 GV 并增加了 TIR。2 毫摩尔/升 [95% CI -0.6, 0.3];P = 0.030 [ITT])。通过变异系数和 SD 估计的 GV 降低在达格列净组中更大。此外,在格列齐特 MR 组中,达格列净将葡萄糖时间范围 (TIR; 3.9-10 mmol/L) 增加了 24.9% (95% CI 18.6, 31.2) 与 17.4% (95% CI 11.6, 23.3) (P = 0.089 [ITT];P = 0.041 [PP])。结论 如 CGM 所示,在 2 型糖尿病患者中,达格列净在 12 周内比格列齐特 MR 更有效地改善了 GV 并增加了 TIR。2 毫摩尔/升 [95% CI -0.6, 0.3];P = 0.030 [ITT])。通过变异系数和 SD 估计的 GV 降低在达格列净组中更大。此外,在格列齐特 MR 组中,达格列净将葡萄糖时间范围 (TIR; 3.9-10 mmol/L) 增加了 24.9% (95% CI 18.6, 31.2) 与 17.4% (95% CI 11.6, 23.3) (P = 0.089 [ITT];P = 0.041 [PP])。结论 如 CGM 所示,在 2 型糖尿病患者中,达格列净在 12 周内比格列齐特 MR 更有效地改善了 GV 并增加了 TIR。P = 0.041 [PP])。结论 如 CGM 所示,在 2 型糖尿病患者中,达格列净在 12 周内比格列齐特 MR 更有效地改善了 GV 并增加了 TIR。P = 0.041 [PP])。结论 如 CGM 所示,在 2 型糖尿病患者中,达格列净在 12 周内比格列齐特 MR 更有效地改善了 GV 并增加了 TIR。
更新日期:2019-12-03
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