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Background <p>While insulin is widely recommended as the first-line pharmacological therapy for gestational diabetes mellitus (GDM), the use of metformin is increasing in routine clinical practice. However, real-world evidence comparing their effectiveness and safety remains limited. This study aimed to evaluate glycemic control and adverse pregnancy outcomes between the insulin and the metformin initiation group in women with GDM in China.</p> Methods <p>We conducted a retrospective cohort study using electronic medical records from a provincial healthcare database in Eastern China. Women diagnosed with GDM between 2018 and 2025 were included. Patients were divided into the insulin initiation group and the metformin initiation group based on their first prescription. Propensity score overlap weighting (OW) was used to balance baseline characteristics. Weighted linear and logistic regression models were used to assess glycemic outcomes, including the glycated hemoglobin (HbA1c) level at the end of pregnancy, the change in HbA1c, and target achievement (HbA1c &lt; 6.0%). Adverse pregnancy outcomes were evaluated using weighted Cox proportional hazards models with gestational age as the time scale.</p> Results <p>Of the 7,397 women included, 6,922 (93.6%) initiated insulin and 475 (6.4%) initiated metformin therapy. After OW adjustment, no significant differences were found between the two groups in end-of-pregnancy HbA1c levels, HbA1c changes, or glycemic control rates. Compared with insulin initiation, metformin initiation was associated with significantly lower risks of cesarean delivery (HR: 0.77, 95% CI: 0.62–0.95; <i>P</i> = 0.017), premature rupture of membranes (HR: 0.66, 95% CI: 0.48–0.93; <i>P</i> = 0.016), and macrosomia (HR: 0.61, 95% CI: 0.40–0.93; <i>P</i> = 0.021). Risks for other adverse outcomes, including preterm birth and preeclampsia, were comparable. Sensitivity analyses, including per-protocol analysis, confirmed the robustness of these findings.</p> Conclusions <p>In this real-world Chinese cohort, the metformin initiation group achieved glycemic control similar to the insulin initiation group. In addition, the metformin initiation group had lower risks of cesarean delivery, premature rupture of membranes, and macrosomia. These findings suggest that metformin may be a viable and effective initial treatment option for selected women with GDM.</p>

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Comparative effectiveness of initiating insulin versus metformin therapy for gestational diabetes mellitus in China: a retrospective cohort study

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  • 发表日期：

    2026年7月31日

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  • Linfeng Jiang,
  • Nan Peng,
  • Mengyao Xue,
  • Ruolan Wei,
  • Guoxian Lu,
  • Yuqing Fan,
  • Shuo Zhang,
  • Beini Lyu,
  • Dongning Yao

摘要

Background

While insulin is widely recommended as the first-line pharmacological therapy for gestational diabetes mellitus (GDM), the use of metformin is increasing in routine clinical practice. However, real-world evidence comparing their effectiveness and safety remains limited. This study aimed to evaluate glycemic control and adverse pregnancy outcomes between the insulin and the metformin initiation group in women with GDM in China.

Methods

We conducted a retrospective cohort study using electronic medical records from a provincial healthcare database in Eastern China. Women diagnosed with GDM between 2018 and 2025 were included. Patients were divided into the insulin initiation group and the metformin initiation group based on their first prescription. Propensity score overlap weighting (OW) was used to balance baseline characteristics. Weighted linear and logistic regression models were used to assess glycemic outcomes, including the glycated hemoglobin (HbA1c) level at the end of pregnancy, the change in HbA1c, and target achievement (HbA1c < 6.0%). Adverse pregnancy outcomes were evaluated using weighted Cox proportional hazards models with gestational age as the time scale.

Results

Of the 7,397 women included, 6,922 (93.6%) initiated insulin and 475 (6.4%) initiated metformin therapy. After OW adjustment, no significant differences were found between the two groups in end-of-pregnancy HbA1c levels, HbA1c changes, or glycemic control rates. Compared with insulin initiation, metformin initiation was associated with significantly lower risks of cesarean delivery (HR: 0.77, 95% CI: 0.62–0.95; P = 0.017), premature rupture of membranes (HR: 0.66, 95% CI: 0.48–0.93; P = 0.016), and macrosomia (HR: 0.61, 95% CI: 0.40–0.93; P = 0.021). Risks for other adverse outcomes, including preterm birth and preeclampsia, were comparable. Sensitivity analyses, including per-protocol analysis, confirmed the robustness of these findings.

Conclusions

In this real-world Chinese cohort, the metformin initiation group achieved glycemic control similar to the insulin initiation group. In addition, the metformin initiation group had lower risks of cesarean delivery, premature rupture of membranes, and macrosomia. These findings suggest that metformin may be a viable and effective initial treatment option for selected women with GDM.