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Introduction <p>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&#xa0;2 diabetes (T2D) duration, HbA1c, and basal insulin dosage using pooled data from the SURPASS-5 and -6 studies.</p> Methods <p>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 &gt; 8.5%), age (&lt; 65&#xa0;years and ≥ 65&#xa0;years), duration of T2D (&lt; 10&#xa0;years and ≥ 10&#xa0;years), and insulin glargine dose (&lt; 50&#xa0;IU/day and ≥ 50&#xa0;IU/day).</p> Results <p>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 (<i>P</i> &lt; 0.001), with no significant heterogeneity (all interaction <i>P</i> values &gt; 0.1). Clinically significant hypoglycemia incidence rates were highest in younger participants with a baseline HbA1c above 8.5% and duration of T2D ≥ 10&#xa0;years.</p> Conclusions <p>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.</p> Trial Registration <p>Trials were registered at ClinicalTrials.gov under the identifiers NCT04039503 (SURPASS-5) and NCT04537923 (SURPASS-6).</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月10日

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

摘要

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).