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Aims/objective <p>The aim of the study was to assess the safety profile (defined as the percentage of patients with at least one hypoglycaemic event [more than 15 min with glucose levels &lt;3.0 mmol/l as documented by continuous glucose monitoring] in the first 4 weeks of follow-up) for insulin degludec/liraglutide (IDegLira) compared with multiple daily insulin injections (MDI) during the transition from hospital to an outpatient setting.</p> Methods <p>The study was an open-label, randomised, controlled clinical trial comparing IDegLira to MDI after hospital discharge in patients with type 2 diabetes. The study evaluated the percentage of patients with at least one hypoglycaemic event, the hypoglycaemia event density, the time in range (TIR 3.8–10 mmol/l), the time below range (TBR &lt;3.0 or &lt;3.8 mmol/l), and other glycaemic management metrics measured by continuous glucose monitoring.</p> Results <p>Sixty-four patients were included in the analysis (32 in each group). They had a baseline HbA<sub>1c</sub> of 103 ± 11.6 mmol/mol (11.6&#xa0;±&#xa0;1.7%) and age of 58&#xa0;±&#xa0;12.4 years (means ± SD). The proportion of patients with at least one hypoglycaemic event (plasma glucose &lt;3.0 mmol/l) was lower in the IDegLira group than in the MDI group (6.2% vs 31.3%; <i>p</i>&lt;0.010), as was the hypoglycaemia event density (incidence rate ratio 15.2; 95% CI 6.2, 48.2; <i>p</i>&lt;0.001), TBR &lt;3.8 mmol/l (0.9% vs 2.9%; <i>p</i>=0.019) and TBR &lt;3.0 mmol/l (0.6% vs 1.3%, <i>p</i>=0.008). The TIR 3.8–10 mmol/l was higher in the IDegLira group (80.6% vs 69.7%; <i>p</i>=0.008). The findings were consistent regardless of baseline HbA<sub>1c</sub>.</p> Conclusions/interpretation <p>IDegLira proved to be safer and more effective than MDI for individuals with type 2 diabetes who had suboptimal glycaemic control, aiding in their transition from hospital to outpatient care.</p> Trial registration <p>Clinicaltrials.gov NCT05767255</p> Funding <p>This research was funded by a grant from the Asociación Colombiana de Endocrinología, Diabetes y Metabolismo (ACE).</p> Graphical Abstract <p></p>

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Insulin DEgludec/LIraglutide versus multiple daily insulin injections in the transition from hospital to outpatient management assessed by continuous glucose monitoring: the DELI transition trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月4日

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  • Ana M. Gómez-Medina,
  • Diana C. Henao-Carillo,
  • Lina P. Villamil-Castañeda,
  • Yaline Gómez-Quesada,
  • Oscar M. Muñoz-Velandia,
  • Carlos A. Yepes,
  • Salma N. Chaim,
  • Carlos E. Pertuz-Noriega,
  • Pablo Aschner

摘要

Aims/objective

The aim of the study was to assess the safety profile (defined as the percentage of patients with at least one hypoglycaemic event [more than 15 min with glucose levels <3.0 mmol/l as documented by continuous glucose monitoring] in the first 4 weeks of follow-up) for insulin degludec/liraglutide (IDegLira) compared with multiple daily insulin injections (MDI) during the transition from hospital to an outpatient setting.

Methods

The study was an open-label, randomised, controlled clinical trial comparing IDegLira to MDI after hospital discharge in patients with type 2 diabetes. The study evaluated the percentage of patients with at least one hypoglycaemic event, the hypoglycaemia event density, the time in range (TIR 3.8–10 mmol/l), the time below range (TBR <3.0 or <3.8 mmol/l), and other glycaemic management metrics measured by continuous glucose monitoring.

Results

Sixty-four patients were included in the analysis (32 in each group). They had a baseline HbA1c of 103 ± 11.6 mmol/mol (11.6 ± 1.7%) and age of 58 ± 12.4 years (means ± SD). The proportion of patients with at least one hypoglycaemic event (plasma glucose <3.0 mmol/l) was lower in the IDegLira group than in the MDI group (6.2% vs 31.3%; p<0.010), as was the hypoglycaemia event density (incidence rate ratio 15.2; 95% CI 6.2, 48.2; p<0.001), TBR <3.8 mmol/l (0.9% vs 2.9%; p=0.019) and TBR <3.0 mmol/l (0.6% vs 1.3%, p=0.008). The TIR 3.8–10 mmol/l was higher in the IDegLira group (80.6% vs 69.7%; p=0.008). The findings were consistent regardless of baseline HbA1c.

Conclusions/interpretation

IDegLira proved to be safer and more effective than MDI for individuals with type 2 diabetes who had suboptimal glycaemic control, aiding in their transition from hospital to outpatient care.

Trial registration

Clinicaltrials.gov NCT05767255

Funding

This research was funded by a grant from the Asociación Colombiana de Endocrinología, Diabetes y Metabolismo (ACE).

Graphical Abstract