一项比较二肽基肽酶 4 抑制剂（利拉利汀）和基础胰岛素（甘精胰岛素）在长期护理和熟练护理设施中 2 型糖尿病患者的随机对照研究：利拉利汀-LTC 试验。
A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Patients With Type 2 Diabetes in Long-term Care and Skilled Nursing Facilities: Linagliptin-LTC Trial.
机构信息
Department of Medicine, Emory University, Atlanta, GA.
Department of Medicine, Emory University, Atlanta, GA.
出版信息
J Am Med Dir Assoc. 2018 May;19(5):399-404.e3. doi: 10.1016/j.jamda.2017.11.002. Epub 2017 Dec 27.
OBJECTIVES
Safe and easily implemented treatment regimens are needed for the management of patients with type 2 diabetes mellitus (T2DM) in long-term care (LTC) and skilled nursing facilities.
DESIGN
This 6-month open-label randomized controlled trial compared the efficacy and safety of a DPP4 inhibitor (linagliptin) and basal insulin (glargine) in LTC residents with T2DM.
SETTINGS
Three LTC institutions affiliated with a community safety-net hospital, US Department of Veterans Affairs and Emory Healthcare System in Atlanta, Georgia.
PARTICIPANTS
A total of 140 residents with T2DM treated with oral antidiabetic agents or low-dose insulin (≤0.1 U/kg/d), with fasting or premeal blood glucose (BG) > 180 mg/dL and/or HbA1c >7.5%.
INTERVENTION
Baseline antidiabetic therapy, except metformin, was discontinued on trial entry. Residents were treated with linagliptin 5 mg/d (n = 67) or glargine at a starting dose of 0.1 U/kg/d (n = 73). Both groups received supplemental rapid-acting insulin before meals for BG > 200 mg/dL.
MEASUREMENTS
Primary outcome was mean difference in daily BG between groups. Main secondary endpoints included differences in frequency of hypoglycemia, glycosylated hemoglobin (HbA1c), complications, emergency department visits, and hospital transfers.
RESULTS
Treatment with linagliptin resulted in no significant differences in mean daily BG (146 ± 34 mg/dL vs. 157 ± 36 mg/dL, P = .07) compared to glargine. Linagliptin treatment resulted in fewer mild hypoglycemic events <70 mg/dL (3% vs. 37%, P < .001), but there were no differences in BG < 54 mg/dL (P = .06) or <40 mg/dL (P = .05) compared to glargine. There were no significant between-group differences in HbA1c, length of stay, complications, emergency department visits, or hospitalizations.
CONCLUSION
Treatment with linagliptin resulted in noninferior glycemic control and in significantly lower risk of hypoglycemia compared to insulin glargine in long-term care and skilled nursing facility residents with type 2 diabetes.
目的
对于长期护理（LTC）和熟练护理机构中的 2 型糖尿病（T2DM）患者，需要安全且易于实施的治疗方案。
设计
这是一项为期 6 个月的开放性标签随机对照试验，比较了 DPP4 抑制剂（利拉利汀）和基础胰岛素（甘精胰岛素）在 LTC 居民中的疗效和安全性。
地点
美国佐治亚州亚特兰大市社区安全网医院、美国退伍军人事务部和埃默里医疗保健系统的三个 LTC 机构。
参与者
共有 140 名接受口服降糖药或低剂量胰岛素（≤0.1 U/kg/d）治疗的 T2DM 患者，空腹或餐前血糖（BG）>180mg/dL 且/或 HbA1c>7.5%。
干预措施
试验入组时停止使用除二甲双胍以外的基线降糖治疗。居民接受利拉利汀 5mg/d（n=67）或甘精胰岛素起始剂量 0.1 U/kg/d（n=73）治疗。两组均在餐前给予速效胰岛素，以控制 BG>200mg/dL。
测量
主要终点是两组间每日 BG 的平均差异。主要次要终点包括低血糖症、糖化血红蛋白（HbA1c）、并发症、急诊就诊和住院转移的频率差异。
结果
与甘精胰岛素相比，利拉利汀治疗并未导致平均每日 BG 出现显著差异（146±34mg/dL 与 157±36mg/dL，P=0.07）。利拉利汀治疗导致低血糖症<70mg/dL 的轻度事件明显减少（3%与 37%，P<0.001），但 BG<54mg/dL（P=0.06）或<40mg/dL（P=0.05）的发生率与甘精胰岛素无差异。两组在 HbA1c、住院时间、并发症、急诊就诊或住院方面无显著差异。
结论
与甘精胰岛素相比，利拉利汀治疗可使 LTC 和熟练护理机构中的 2 型糖尿病患者的血糖控制达到非劣效性，且低血糖风险显著降低。
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