Tirzepatide as an Add-on for Participants with Inadequate Glycemic Control Using Basal Insulin: Pooled Subgroup Analysis of SURPASS-5 and -6.

IF 4.2 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2026-05-01 Epub Date: 2026-04-10 DOI:10.1007/s13300-026-01859-3

Harpreet S Bajaj, Liana K Billings, Palash Sharma, Joshua A Levine, Angel Rodriguez, Hiren Patel

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Abstract

Introduction: This study aimed to assess the efficacy and hypoglycemia safety of tirzepatide as an add-on to basal insulin in people with inadequate glycemic control, across subgroups of baseline age, type 2 diabetes (T2D) duration, HbA1c, and basal insulin dosage using pooled data from the SURPASS-5 and -6 studies.

Methods: This exploratory post hoc analysis compared data from 1072 participants treated with tirzepatide as an add-on to basal insulin in SURPASS-5 and SURPASS-6. In SURPASS-5, tirzepatide was compared against placebo, while in SURPASS-6, it was compared with insulin lispro. Insulins were titrated to the target in both trials. Subgroups were divided by baseline HbA1c (≤ 8.5% and > 8.5%), age (< 65 years and ≥ 65 years), duration of T2D (< 10 years and ≥ 10 years), and insulin glargine dose (< 50 IU/day and ≥ 50 IU/day).

Results: At the primary endpoint, tirzepatide added to basal insulin glargine was associated with significant reductions in HbA1c, fasting serum glucose, and insulin glargine dose across all subgroups (P < 0.001), with no significant heterogeneity (all interaction P values > 0.1). Clinically significant hypoglycemia incidence rates were highest in younger participants with a baseline HbA1c above 8.5% and duration of T2D ≥ 10 years.

Conclusions: In this study, tirzepatide combined with basal insulin glargine was associated with reductions in HbA1c, fasting serum glucose, and insulin glargine dose from baseline, with a low incidence of hypoglycemia, regardless of baseline age, HbA1c, duration of T2D, or basal insulin dose.

Trial registration: Trials were registered at ClinicalTrials.gov under the identifiers NCT04039503 (SURPASS-5) and NCT04537923 (SURPASS-6).

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替西肽作为基础胰岛素控制血糖不足患者的附加治疗：SURPASS-5和-6的合并亚组分析

本研究旨在利用来自SURPASS-5和-6研究的汇总数据，跨基线年龄、2型糖尿病（T2D）持续时间、HbA1c和基础胰岛素剂量亚组，评估替西帕肽作为基础胰岛素补充治疗对血糖控制不充分人群的疗效和降糖安全性。方法：这项探索性事后分析比较了1072名参与者在SURPASS-5和SURPASS-6中使用替西帕肽作为基础胰岛素的补充治疗的数据。在SURPASS-5中，替西帕肽与安慰剂进行了比较，而在SURPASS-6中，替西帕肽与胰岛素利斯普罗进行了比较。在两项试验中，胰岛素都被滴定到目标。亚组按基线HbA1c（≤8.5%和bb0 8.5%）、年龄划分。结果：在主要终点，在基础甘精胰岛素中加入替西帕肽与所有亚组中HbA1c、空腹血糖和甘精胰岛素剂量的显著降低相关（P 0.1）。基线HbA1c高于8.5%且T2D持续时间≥10年的年轻参与者中，临床显著性低血糖发生率最高。结论：在本研究中，替西帕肽联合基础甘精胰岛素与HbA1c、空腹血糖和甘精胰岛素剂量较基线降低相关，低血糖发生率低，与基线年龄、HbA1c、t2dm持续时间或基础胰岛素剂量无关。试验注册：试验在ClinicalTrials.gov上注册，标识符为NCT04039503 （SURPASS-5）和NCT04537923 （SURPASS-6）。

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 Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.