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Background <p>Diabetes in pregnancy is associated with increased maternal and fetal risks, including preterm birth, preeclampsia, and neonatal complications. While insulin glargine U300 offers a stable pharmacokinetic profile and reduced hypoglycemia in non-pregnant populations, data on its safety and effectiveness during pregnancy are limited.&#xa0;</p> Objective <p>This study aimed to evaluate maternal and fetal outcomes in pregnant women with pre-existing diabetes treated with glargine U300 in a real-world setting.</p> Methods <p>This was a multicenter, retrospective observational study conducted across eight diabetes clinics in India from 2015 to 2023. A total of 132 pregnant women with pre-existing type 1, type 2, or LADA diabetes who were initiated on glargine U300 prior to conception were included. All patients received basal–bolus insulin therapy with or without metformin. Data were extracted from electronic medical records and included glycemic parameters, insulin dose titration, hypoglycemia, ketosis, and pregnancy outcomes. Descriptive and inferential statistics were used for analysis.</p> Results <p>The mean age of participants was 34.2 ± 3.8&#xa0;years, and the average diabetes duration was 2.8 ± 3.17&#xa0;years. The live birth rate was 88.6%, and cesarean section was the predominant mode of delivery (87.1%). No serious maternal or neonatal adverse events were attributed to glargine U300. Hypoglycemia occurred in 8.3% of women, and two cases of ketosis were reported, all managed without complications. Fetal outcomes were favorable, with a mean birth weight of 2.9 ± 0.3&#xa0;kg and five preterm births. Among the 96 women with no comorbidities other than diabetes, 94% had live births.</p> Conclusion <p>Glargine U300, when initiated prior to pregnancy and used throughout gestation as part of a basal–bolus regimen, appears to be well tolerated and potentially effective for glycemic control in women with pre-existing diabetes. While the findings are promising, larger prospective studies are needed to validate the safety and efficacy of glargine U300 in pregnancy.</p>

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Real-world evidence of the use of glargine U300 in the treatment of pre-existing diabetes in pregnant women

  • 期刊论文

  • 发表日期：

    2026年1月9日

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  • Rutul Gokalani,
  • Shalini Jaggi,
  • Dharmendra Panchal,
  • Shambo Samrat Samajdar,
  • Amit Kumar Dey,
  • Ninad Gor,
  • Dipak Chudasama,
  • Anuj Maheshwari

摘要

Background

Diabetes in pregnancy is associated with increased maternal and fetal risks, including preterm birth, preeclampsia, and neonatal complications. While insulin glargine U300 offers a stable pharmacokinetic profile and reduced hypoglycemia in non-pregnant populations, data on its safety and effectiveness during pregnancy are limited. 

Objective

This study aimed to evaluate maternal and fetal outcomes in pregnant women with pre-existing diabetes treated with glargine U300 in a real-world setting.

Methods

This was a multicenter, retrospective observational study conducted across eight diabetes clinics in India from 2015 to 2023. A total of 132 pregnant women with pre-existing type 1, type 2, or LADA diabetes who were initiated on glargine U300 prior to conception were included. All patients received basal–bolus insulin therapy with or without metformin. Data were extracted from electronic medical records and included glycemic parameters, insulin dose titration, hypoglycemia, ketosis, and pregnancy outcomes. Descriptive and inferential statistics were used for analysis.

Results

The mean age of participants was 34.2 ± 3.8 years, and the average diabetes duration was 2.8 ± 3.17 years. The live birth rate was 88.6%, and cesarean section was the predominant mode of delivery (87.1%). No serious maternal or neonatal adverse events were attributed to glargine U300. Hypoglycemia occurred in 8.3% of women, and two cases of ketosis were reported, all managed without complications. Fetal outcomes were favorable, with a mean birth weight of 2.9 ± 0.3 kg and five preterm births. Among the 96 women with no comorbidities other than diabetes, 94% had live births.

Conclusion

Glargine U300, when initiated prior to pregnancy and used throughout gestation as part of a basal–bolus regimen, appears to be well tolerated and potentially effective for glycemic control in women with pre-existing diabetes. While the findings are promising, larger prospective studies are needed to validate the safety and efficacy of glargine U300 in pregnancy.