中国 2 型糖尿病患者短期强化胰岛素治疗后基于基础胰岛素与每日两次预混胰岛素治疗的疗效和安全性：一项随机对照试验的研究方案（BEYOND V）。

Efficacy and Safety of Basal Insulin-Based Treatment Versus Twice-Daily Premixed Insulin After Short-Term Intensive Insulin Therapy in Patients with Type 2 Diabetes Mellitus in China: Study Protocol for a Randomized Controlled Trial (BEYOND V).

机构信息

Endocrinology Department, Gansu Provincial People's Hospital, Lanzhou, China.

Endocrinology Department, Tianjin First Center Hospital, Tianjin, China.

出版信息

Adv Ther. 2020 Apr;37(4):1675-1687. doi: 10.1007/s12325-020-01265-6. Epub 2020 Mar 4.

DOI:10.1007/s12325-020-01265-6

PMID:32130661

Abstract

INTRODUCTION

Many Chinese patients who are uncontrolled by oral antidiabetic drugs (OADs) receive short-term intensive insulin therapy (IIT) in hospital to rapidly relieve glucose-associated toxicity and to preserve/improve β-cell function. However, evidence for optimizing insulin algorithms for maintenance treatment after IIT is lacking. This study will compare the efficacy and safety of basal insulin-based treatment versus twice-daily premixed insulin in type 2 diabetes mellitus (T2DM) patients after short-term in-hospital IIT.

METHODS

This 26-week randomized, multicenter, positive-controlled, open-label, parallel-group study will enroll approximately 400 male and female patients aged 18-70 years with poorly-controlled T2DM (HbA1c > 7.5%) despite treatment with metformin plus at least one other OAD for 8 or more weeks. During a run-in period of 7-10 days, patients will be treated in-hospital with IIT comprising insulin glargine (Lantus) once daily and insulin glulisine (Apidra) three times daily; both regimens will be titrated daily to achieve the glycemic goal. Eligible patients will then be randomized in a 1:1 ratio to insulin glargine plus OADs or twice-daily premixed insulin (NovoLog Mix 70/30) for 24 weeks, with metformin maintained throughout the study in both treatment groups. The primary endpoint is HbA1c change from baseline to week 24. Secondary endpoints include assessment of fasting plasma glucose, total daily insulin dose, hypoglycemia incidence, body weight change, adverse events, and patient satisfaction.

DISCUSSION

Given the current lack of clinical data, this study will provide evidence supporting safe and effective glycemic control using basal insulin glargine-based therapy plus OADs compared with twice-daily premixed insulin in Chinese patients with T2DM after short-term IIT. This will assist physicians by providing a wider choice of treatments.

TRIAL REGISTRATION

ClinicalTrials.gov identifier, NCT03359837 (registered on 2 December 2017).

摘要

简介

许多口服降糖药（OAD）控制不佳的中国患者在医院接受短期强化胰岛素治疗（IIT），以迅速缓解葡萄糖相关毒性并维持/改善β细胞功能。然而，缺乏 IIT 后优化胰岛素治疗方案的证据。本研究将比较基础胰岛素为基础的治疗与预混胰岛素（诺和锐 30）在短期院内 IIT 后 2 型糖尿病（T2DM）患者中的疗效和安全性。

方法

这是一项为期 26 周的随机、多中心、阳性对照、开放标签、平行组研究，将纳入约 400 名年龄在 18-70 岁的男性和女性 T2DM 患者，这些患者尽管接受二甲双胍联合至少一种其他 OAD 治疗 8 周或更长时间，但血糖仍控制不佳（HbA1c>7.5%）。在为期 7-10 天的导入期内，患者将接受 IIT 治疗，包括每日一次甘精胰岛素（来得时）和每日三次赖脯胰岛素（优泌乐）；两种方案均每日滴定以达到血糖目标。符合条件的患者随后以 1:1 的比例随机分为胰岛素甘精胰岛素联合 OAD 或预混胰岛素（诺和锐 30）治疗 24 周，两组均在整个研究期间维持使用二甲双胍。主要终点是从基线到第 24 周的 HbA1c 变化。次要终点包括空腹血糖、总日胰岛素剂量、低血糖发生率、体重变化、不良事件和患者满意度的评估。