A Randomized Controlled Trial Comparing the Efficacy and Safety of IDegLira Versus Basal-Bolus in Patients With Poorly Controlled Type 2 Diabetes and Very High HbA1c ≥9-15%: DUAL HIGH Trial.

IF 14.8 1区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes Care Pub Date : 2023-09-01 DOI:10.2337/dc22-2426

Rodolfo J Galindo, Bobak Moazzami, Maria F Scioscia, Cesar Zambrano, Bonnie S Albury, Jarrod Saling, Priyathama Vellanki, Francisco J Pasquel, Georgia M Davis, Maya Fayfman, Limin Peng, Guillermo E Umpierrez

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Abstract

Objective: In participants with type 2 diabetes (T2D) and HbA1c >9.0-10.0%, guidelines recommend treatment with basal-bolus insulin.

Research design and methods: This randomized trial compared the efficacy and safety of insulin degludec and liraglutide (IDegLira) and basal-bolus among participants with high HbA1c ≥9.0-15.0%, previously treated with 2 or 3 oral agents and/or basal insulin, allocated (1:1) to basal-bolus (n = 73) or IDegLira (n = 72). The primary end point was noninferiority (0.4%) in HbA1c reduction between groups.

Results: Among 145 participants (HbA1c 10.8% ± 1.3), there was no statistically significant difference in HbA1c reduction (3.18% ± 2.29 vs. 3.00% ± 1.79, P = 0.65; estimated treatment difference (ETD) 0.18%, 95% CI -0.59, 0.94) between the IDegLira and basal-bolus groups. IDegLira resulted in significantly lower rates of hypoglycemia <70 mg/dL (26% vs. 48%, P = 0.008; odds ratio 0.39, 95% CI 0.19, 0.78), and less weight gain (1.24 ± 8.33 vs. 5.84 ± 6.18 kg, P = 0.001; ETD -4.60, 95% CI -7.33, -1.87).

Conclusions: In participants with T2D and HbA1c ≥9.0-15.0%, IDegLira resulted in similar HbA1c reduction, less hypoglycemia, and less weight gain compared with the basal-bolus regimen.

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比较 IDegLira 与 Basal-Bolus 对控制不佳且 HbA1c ≥9-15% 的 2 型糖尿病患者的疗效和安全性的随机对照试验：DUAL HIGH 试验。

研究目的对于 HbA1c >9.0-10.0% 的 2 型糖尿病（T2D）患者，指南建议使用基础胰岛素治疗：这项随机试验比较了胰岛素degludec和利拉鲁肽（IDegLira）和基础胰岛素的疗效和安全性，研究对象为HbA1c≥9.0-15.0%，曾接受过2或3种口服药物和/或基础胰岛素治疗的患者，分配（1:1）至基础胰岛素（n = 73）或IDegLira（n = 72）。主要终点是各组间 HbA1c 降低率的非劣效性（0.4%）：在 145 名参与者（HbA1c 10.8% ± 1.3）中，IDegLira 组和基础药物组在 HbA1c 降低率方面没有显著统计学差异（3.18% ± 2.29 vs. 3.00% ± 1.79，P = 0.65；估计治疗差异 (ETD) 0.18%，95% CI -0.59, 0.94）。IDegLira 能显著降低低血糖发生率结论：IDegLira 能显著降低低血糖发生率：对于 HbA1c≥9.0-15.0% 的 T2D 患者，IDegLira 可使 HbA1c 降低，低血糖发生率降低，体重增加率降低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetes Care 医学-内分泌学与代谢

CiteScore

27.80

自引率

4.90%

发文量

449

审稿时长

1 months

期刊介绍： The journal's overarching mission can be captured by the simple word "Care," reflecting its commitment to enhancing patient well-being. Diabetes Care aims to support better patient care by addressing the comprehensive needs of healthcare professionals dedicated to managing diabetes. Diabetes Care serves as a valuable resource for healthcare practitioners, aiming to advance knowledge, foster research, and improve diabetes management. The journal publishes original research across various categories, including Clinical Care, Education, Nutrition, Psychosocial Research, Epidemiology, Health Services Research, Emerging Treatments and Technologies, Pathophysiology, Complications, and Cardiovascular and Metabolic Risk. Additionally, Diabetes Care features ADA statements, consensus reports, review articles, letters to the editor, and health/medical news, appealing to a diverse audience of physicians, researchers, psychologists, educators, and other healthcare professionals.

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