Ling James, Poon Emily W M, Yang Aimin, Yeung Theresa, Loo Kitman, Ozaki Risa, Ma Ronald C W, Luk Andrea O Y, Kong Alice P S, Chan Juliana C N, Chow Elaine
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong Special Administrative Region, China.
Hong Kong Institute of Diabetes and Obesity, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong Special Administrative Region, China.
Diabetes Ther. 2021 May;12(5):1399-1413. doi: 10.1007/s13300-021-01046-6. Epub 2021 Mar 18.
To compare glycemic variability (GV) and time in range (TIR) in Chinese patients with type 2 diabetes (T2D) initiated on once-daily bedtime insulin glargine 300U/ml (Gla-300) versus neutral protamine Hagedorn (NPH) insulin using continuous glucose monitoring (CGM).
This was a 24-week, open-label exploratory study with 1:1 randomization comparing patient-adjusted titration of Gla-300 (n = 23) versus NPH (n = 23) at bedtime in insulin-naïve T2D patients on maximum oral glucose-lowering drugs. The starting dose was 0.2 U/kg/day and with self-titration of one unit per week to achieve a target fasting glucose of 4.4-6 mmol/l, without hypoglycemia. Participants had masked CGM at baseline, weeks 11 and 24. The primary outcome was between-treatment differences in CGM glucose standard deviation (SD) at week 24.
HbA1c at week 24 were similar, with 21% of Gla-300 versus 4% of NPH-treated patients achieving HbA1c < 7% without confirmed hypoglycemia. There were no differences in anytime glucose SD at week 24 (LS mean difference - 0.08 mmol/l, 95% CI [- 0.42-0.26], p = 0.63). Anytime %TIRs (3.9-10.0 mmol/l) at week 24 were similar (p = 0.91). Nocturnal % time below range < 3.9 mmol/l was significantly lower in the Gla-300 group (least squares (LS) mean difference - 5.03% [- 9.92 to - 0.14], p = 0.04) with lower % coefficient of variation (LS mean difference - 4.5% [- 8.1 to - 0.8], p = 0.018). Diurnal TIR was higher in Gla-300 patients at week 11 but there were no differences at week 24.
Once-daily bedtime Gla-300 was associated with lower nocturnal GV, time below range and self-reported hypoglycemia in insulin-naïve Chinese T2D patients over a 24-week study period, as compared with NPH insulin.
ClinicalTrials.gov Identifier: NCT03389490.
使用连续血糖监测（CGM）比较起始每日一次睡前注射300U/ml甘精胰岛素（Gla-300）与中性鱼精蛋白锌胰岛素（NPH）的中国2型糖尿病（T2D）患者的血糖变异性（GV）和血糖达标时间（TIR）。
这是一项为期24周的开放标签探索性研究，1:1随机分组，比较初治T2D患者在睡前接受Gla-300（n = 23）与NPH（n = 23）的患者调整剂量滴定，这些患者正在接受最大剂量的口服降糖药物治疗。起始剂量为0.2U/kg/天，每周自行滴定1个单位，以达到空腹血糖目标为4.4 - 6mmol/l，且无低血糖。参与者在基线、第11周和第24周进行了CGM监测。主要结局是第24周时CGM血糖标准差（SD）的组间差异。
第24周时糖化血红蛋白（HbA1c）相似，21%接受Gla-300治疗的患者与4%接受NPH治疗的患者在未确认低血糖的情况下HbA1c < 7%。第24周时任何时间点的血糖SD无差异（最小二乘均值差 - 0.08mmol/l，95%CI[-0.42 - 0.26]，p = 0.63）。第24周时任何时间点的血糖达标时间百分比（3.9 - 10.0mmol/l）相似（p = 0.91）。Gla-300组夜间血糖低于范围< 3.9mmol/l的时间百分比显著更低（最小二乘（LS）均值差 - 5.03%[-9.92至 - 0.14]，p = 0.04），变异系数百分比更低（LS均值差 - 4.5%[-8.1至 - 0.8]，p = 0.018）。第11周时Gla-300组患者的日间血糖达标时间更高，但第24周时无差异。
在一项为期24周的研究中，与NPH胰岛素相比，初治中国T2D患者每日一次睡前注射Gla-300与更低的夜间GV、血糖低于范围的时间和自我报告的低血糖相关。
ClinicalTrials.gov标识符：NCT03389490。
