The University of Jordan School of Medicine, Amman, Jordan.
Hunter-New England Health, New Lambton, NSW, Australia.
Front Endocrinol (Lausanne). 2021 Jul 7;12:613826. doi: 10.3389/fendo.2021.613826. eCollection 2021.
We aimed to investigate the effect of dosage reduction of four hypoglycemic multidrug regimens on the incidences of acute glycemic complications in people with type 2 diabetes who fast during Ramaḍān.
We conducted an open-label, parallel-group, randomized controlled trial at a tertiary care center in Amman, Jordan. We recruited adults with type 2 diabetes who expressed an intention to fast during Ramaḍān and were adherent to one of four regimens-namely: metformin and glimepiride; metformin and vildagliptin; metformin and insulin glargine U100; or, metformin, insulin glargine U100, and human regular insulin. We randomly assigned participants in a 2:1 ratio to low- or regular-dosage therapy. The primary outcomes were the incidences of hypoglycemia and hyperglycemia during the 29 days of Ramaḍān 2017, and the secondary outcomes were the incidences of diabetic ketoacidosis and hyperosmolar hyperglycemic state during the same period.
We randomly assigned 687 participants to low-dosage therapy ( = 458) or regular-dosage therapy ( = 229) and included 678 (452 and 226, respectively) in the final analysis. The incidence of hypoglycemia was lower in the low-dosage group compared with the regular-dosage group (19 [4.2%] vs. 52 [23.0%], respectively; OR, 0.15 [95% CI, 0.08-0.26]; < 0.001). The incidence of hyperglycemia did not differ between the low- and regular-dosage groups (319 [70.6%] vs. 154 [68.1%], respectively; OR, 1.12 [95% CI, 0.79-1.58]; = 0.5). No participants experienced diabetic ketoacidosis or hyperosmolar hyperglycemic state. Each 1% decrease in the baseline HbA concentration was associated with a 19.9-fold (95% CI, 9.6-41.5; < 0.001) increase in the odds of hypoglycemia, and each 1% increase in the baseline HbA concentration was associated with a 15.7-fold (95% CI, 10.0-24.6; < 0.001) increase in the odds of hyperglycemia.
Dosage reduction decreases the incidence of hypoglycemia without a concomitant increase in the incidences of hyperglycemia, diabetic ketoacidosis, and hyperosmolar hyperglycemic state in people with type 2 diabetes who fast during Ramaḍān.
www.ClinicalTrials.gov, identifier NCT04237493.
我们旨在研究在斋月期间禁食的 2 型糖尿病患者减少四种降糖多药物方案的剂量对急性血糖并发症发生率的影响。
我们在约旦安曼的一家三级护理中心进行了一项开放标签、平行组、随机对照试验。我们招募了表示打算在斋月期间禁食且坚持使用以下四种方案之一的成年 2 型糖尿病患者：二甲双胍和格列美脲；二甲双胍和维格列汀；二甲双胍和胰岛素甘精 U100；或二甲双胍、胰岛素甘精 U100 和人普通胰岛素。我们以 2:1 的比例将参与者随机分配至低剂量或常规剂量治疗组。主要结局为 2017 年斋月的 29 天内发生低血糖和高血糖的发生率，次要结局为同期发生糖尿病酮症酸中毒和高渗高血糖状态的发生率。
我们将 687 名参与者随机分配至低剂量治疗组（n=458）或常规剂量治疗组（n=229），并将 678 名（分别为 452 名和 226 名）参与者纳入最终分析。与常规剂量组相比，低剂量组的低血糖发生率较低（19[4.2%] vs. 52[23.0%]，分别；OR，0.15[95%CI，0.08-0.26]；<0.001）。低血糖和高血糖的发生率在低剂量组和常规剂量组之间无差异（分别为 319[70.6%] vs. 154[68.1%]，OR，1.12[95%CI，0.79-1.58]；=0.5）。无参与者发生糖尿病酮症酸中毒或高渗高血糖状态。HbA1c 基线浓度每降低 1%，低血糖的可能性增加 19.9 倍（95%CI，9.6-41.5；<0.001），HbA1c 基线浓度每增加 1%，高血糖的可能性增加 15.7 倍（95%CI，10.0-24.6；<0.001）。
在斋月期间禁食的 2 型糖尿病患者中，减少剂量可降低低血糖的发生率，而不会增加高血糖、糖尿病酮症酸中毒和高渗高血糖状态的发生率。
www.ClinicalTrials.gov，标识符 NCT04237493。
