Diabetes remission and relapse following an intensive metabolic intervention combining insulin glargine/lixisenatide, metformin and lifestyle approaches: Results of a randomised controlled trial

IF 5.4 2区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes, Obesity & Metabolism Pub Date : 2023-08-14 DOI:10.1111/dom.15234

Natalia McInnes MD, Stephanie Hall BHA, Heather A. Lochnan MD, Stewart B. Harris MD, Zubin Punthakee MD, Ronald J. Sigal MD, Irene Hramiak MD, Mohammed Azharuddin MD, Joanne F. Liutkus MD, Jean-Fran?ois Yale MD, Farah Sultan MSc, Ada Smith BScN, Rose E. Otto BASc, Diana Sherifali PhD, Yan Yun Liu MSc, Hertzel C. Gerstein MD, the REMIT-iGlarLixi Collaborative Group

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引用次数: 1

Abstract

Aim

Non-surgical options for inducing type 2 diabetes remission are limited. We examined whether remission can be achieved by combining lifestyle approaches and short-term intensive glucose-lowering therapy.

Methods

In this trial, 160 patients with type 2 diabetes on none to two diabetes medications other than insulin were randomised to (a) an intervention comprising lifestyle approaches, insulin glargine/lixisenatide and metformin, or (b) standard care. Participants with glycated haemoglobin (HbA1c) <7.3% (56 mmol/mol) at 12 weeks were asked to stop diabetes medications and were followed for an additional 52 weeks. The primary outcome was diabetes relapse defined as HbA1c ≥6.5% (48 mmol/mol) at 24 weeks or thereafter, capillary glucose ≥10 mmol/L on ≥50% of readings, or use of diabetes medications, analysed as time-to-event. Main secondary outcomes included complete or partial diabetes remission at 24, 36, 48 and 64 weeks defined as HbA1c <6.5% (48 mmol/mol) off diabetes medications since 12 weeks after randomisation. A hierarchical testing strategy was applied.

Results

The intervention significantly reduced the hazard of diabetes relapse by 43% (adjusted hazard ratio 0.57, 95% confidence interval 0.40-0.81; p = .002). Complete or partial diabetes remission was achieved in 30 (38.0%) intervention group participants versus 16 (19.8%) controls at 24 weeks and 25 (31.6%) versus 14 (17.3%) at 36 weeks [relative risk 1.92 (95% confidence interval 1.14-3.24) and 1.83 (1.03-3.26), respectively]. The relative risk of diabetes remission in the intervention versus control group was 1.88 (1.00-3.53) at 48 weeks and 2.05 (0.98-4.29) at 64 weeks.

Conclusions

A 12-week intensive intervention comprising insulin glargine/lixisenatide, metformin and lifestyle approaches can induce remission of diabetes.

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强化代谢干预结合甘精胰岛素/利西那肽、二甲双胍和生活方式治疗后糖尿病的缓解和复发：一项随机对照试验的结果

目的诱导2型糖尿病缓解的非手术选择是有限的。我们研究了是否可以通过结合生活方式和短期强化降糖治疗来实现病情缓解。方法在这项试验中，160名2型糖尿病患者被随机分为（a）包括生活方式方法、甘精胰岛素/利西那肽和二甲双胍的干预措施，或（b）标准护理。糖化血红蛋白（HbA1c）<；7.3%（56 mmol/mol）在12 几周后被要求停止服用糖尿病药物，并被随访了52周周。主要结果是糖尿病复发，定义为HbA1c≥6.5%（48 mmol/mol）在24 周或之后，毛细血管葡萄糖≥10 mmol/L≥50%的读数，或使用糖尿病药物，作为事件发生时间进行分析。主要次要结果包括24、36、48和64岁时糖尿病完全或部分缓解周定义为HbA1c<；6.5%（48 mmol/mol）自12日起停用糖尿病药物随机化后数周。采用了分层测试策略。结果干预显著降低了43%的糖尿病复发风险（调整后的风险比为0.57，95%置信区间为0.40-0.81；p = .002）。30名（38.0%）干预组参与者的糖尿病完全或部分缓解，而16名（19.8%）对照组参与者在24 周和25周（31.6%），而36周时为14周（17.3%）周[相对风险分别为1.92（95%置信区间1.14-3.24）和1.83（1.03-3.26）]。干预组与对照组在48岁时糖尿病缓解的相对风险为1.88（1.00-3.53）第64周为2.05（0.98-4.29）周。结论强化干预12周，包括甘精胰岛素/利西那肽、二甲双胍和生活方式可以诱导糖尿病的缓解。

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来源期刊

Diabetes, Obesity & Metabolism 医学-内分泌学与代谢

CiteScore

10.90

自引率

6.90%

发文量

319

审稿时长

3-8 weeks

期刊介绍： Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.