Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Beijing, China.
Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
Diabetes Obes Metab. 2022 Oct;24(10):1957-1966. doi: 10.1111/dom.14780. Epub 2022 Jun 28.
To compare the efficacy and safety of basal insulin glargine 100 units/ml (Gla) + 2-3 oral antihyperglycaemic drugs (OADs) with twice-daily premixed insulin aspart 70/30 (Asp30) + metformin (MET) after short-term intensive insulin therapy in adults with type 2 diabetes in China.
This open-label trial enrolled insulin-naïve adults with type 2 diabetes and an HbA1c of 7.5%-11.0% (58-97 mmol/mol) despite treatment with 2-3 OADs. All participants stopped previous OADs except MET, then received short-term intensive insulin therapy during the run-in period, when those with a fasting plasma glucose of less than 7.0 mmol/L and 2-hour postprandial glucose of less than 10.0 mmol/L were randomized to Gla + MET + a dipeptidyl peptidase-4 inhibitor or twice-daily Asp30 + MET. If HbA1c was more than 7.0% (>53 mmol/mol) at week 12, participants in the Gla group were added repaglinide or acarbose, at the physician's discretion, and participants in the Asp30 group continued to titrate insulin dose. The change in HbA1c from baseline to week 24 was assessed in the per protocol (PP) population (primary endpoint).
There were 384 enrollees (192 each to Gla and Asp30); 367 were included in the PP analysis. The threshold for non-inferiority of Gla + OADs versus Asp30 + MET was met, with a least squares mean change from baseline in HbA1c of -1.72% and -1.70% (-42.2 and -42.1 mmol/mol), respectively (estimated difference -0.01%; 95% CI -0.20%, 0.17% [-0.1 mmol/mol; 95% CI -2.2, 1.9]). Achievement of HbA1c less than 7.0% (<53 mmol/mol) was comparable between the groups (60% vs. 57%). The proportion of participants with any (24% vs. 38%; P = .003), symptomatic (19% vs. 31%; P = .007) or confirmed hypoglycaemia (18% vs. 33%; P < .001) was lower in the Gla + OADs group.
Compared with Asp30 + MET, Gla + 2-3 OADs showed similar efficacy but a lower hypoglycaemia risk in Chinese individuals with type 2 diabetes who had undergone short-term intensive insulin therapy.
比较短期强化胰岛素治疗后，基础胰岛素甘精 100 单位/毫升（Gla）+2-3 种口服降糖药（OAD）与预混胰岛素门冬胰岛素 30 70/30（Asp30）+二甲双胍（MET）在我国 2 型糖尿病成人中的疗效和安全性。
这项开放标签试验纳入了胰岛素初治、HbA1c 为 7.5%-11.0%（58-97mmol/mol）的 2 型糖尿病成人，这些患者在接受 2-3 种 OAD 治疗的情况下仍未达标。所有参与者在导入期停止之前的 OAD 治疗，但保留 MET，然后接受短期强化胰岛素治疗，当空腹血糖<7.0mmol/L 和餐后 2 小时血糖<10.0mmol/L 时，他们被随机分配至 Gla+MET+二肽基肽酶-4 抑制剂或每日 2 次 Asp30+MET。如果第 12 周时 HbA1c>7.0%（>53mmol/mol），Gla 组的参与者可根据医生的判断加用餐时促胰岛素分泌剂瑞格列奈或阿卡波糖，而 Asp30 组的参与者继续调整胰岛素剂量。以（主要终点）方案人群（PP 人群）中从基线到第 24 周的 HbA1c 变化来评估。
共纳入 384 名参与者（每组 192 名）；367 名参与者纳入 PP 分析。Gla+OAD 不劣于 Asp30+MET 的阈值得到满足，HbA1c 的最小二乘均值变化分别为-1.72%和-1.70%（-42.2 和-42.1mmol/mol）（估计差值 0.01%；95%CI-0.20%，0.17%[-0.1mmol/mol；95%CI-2.2，1.9]）。两组达到 HbA1c<7.0%（<53mmol/mol）的比例相当（60% vs. 57%）。Gla+OAD 组任何（24% vs. 38%；P=0.003）、症状性（19% vs. 31%；P=0.007）或确诊的低血糖（18% vs. 33%；P<0.001）的发生率均低于 Asp30+MET 组。
与 Asp30+MET 相比，在中国接受短期强化胰岛素治疗的 2 型糖尿病患者中，Gla+2-3 种 OAD 显示出相似的疗效，但低血糖风险较低。
