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[메디칼업저버 박선혜 기자] Pregnant women who need to control their blood sugar levels have been found to receive no additional benefit from metformin while taking insulin, which is the standard treatment.
The MOMPOD randomized trial found that treatment with metformin together with insulin did not reduce the risk of developing neonatal complications in pregnant women who had type 2 diabetes or who were diagnosed with diabetes early in pregnancy.
The results of this study were published in the December issue of JAMA (JAMA 2023;330(22):2182~2190).
The first-line treatment for patients with type 2 diabetes is metformin, but guidelines recommend insulin as the standard treatment for pregnant women who have type 2 diabetes or who have gestational diabetes.
However, multiple insulin treatments for pregnant women can cause weight gain and hypoglycemia, making treatment difficult. The incidence of adverse reactions has also been reported to increase in both the mother and fetus with insulin treatment.
Meanwhile, there was a question of whether pregnant women taking metformin while taking insulin would reduce their risk of a poor neonatal prognosis.
This study was conducted under the assumption that neonatal prognosis would be improved with combined treatment with insulin and metformin.
From April 2019 to November 2021, 794 pregnant women ages 18 to 45 who had type 2 diabetes or were diagnosed with diabetes before 23 weeks of pregnancy were enrolled in the study at 17 medical institutions across the United States . The average age was 32.9 years and 78% already had type 2 diabetes.
The entire group of patients was randomly assigned to the insulin + metformin group (metformin group, 397 patients) and the insulin + placebo group (placebo group, 397 patients). Metformin 1,000 mg and placebo were to be taken twice daily from 11 to 23 weeks of gestation at registration until delivery. Follow-up observations were conducted until May 2022.
The primary endpoint was defined as multiple neonatal complications including perinatal death, preterm delivery, large for gestational age or small for gestational age, and hyperbilirubinemia requiring phototherapy. A small-for-gestational-age baby refers to a fetus born large for its gestational age, while a small-for-gestational-age baby refers to a fetus born small. Predefined secondary endpoints included maternal hypoglycemia and neonatal adiposity at birth.
As a result of the investigation, the primary target incidence rate was 71% in the metformin group and 74% in the placebo group, with no significant difference between the two groups (adjusted OR 0.86; 95% CI 0.63~1, 19). In other words, adding metformin to insulin did not significantly reduce the risk of developing complex neonatal complications.
The most common neonatal complications in both groups were preterm birth, neonatal hypoglycemia, and newborn birth weight. Secondary endpoints and subanalysis results were also similar for the two groups.
This study was deemed to have limitations in identifying significant differences in the primary endpoint between the two groups and was stopped at the incidence rate of 75% of the primary endpoint.
However, among factors assessed for complex neonatal complications, the rate of preterm birth in the metformin group was 26%, which was 10 percentage points lower than the 36% in the placebo group. The probability of having a gestational weight baby in the metformin group was significantly lower by 37% compared to the placebo group (adjusted OR 0.63; 95% CI 0.46-0.86).
Professor Kim Boggess of the University of North Carolina, USA, who led the study, said: “In this study, pregnant women who had type 2 diabetes or who had been diagnosed with diabetes early in their pregnancy were more likely to develop complex neonatal complications even if he took metformin while taking insulin to control blood sugar levels. “We confirmed that it did not decrease,” he said. “However, when metformin was added, the possibility of a baby with gestational weight was significantly lower. Further investigation into this is necessary.”
Unlike this study, the MiTy study published in 2020 reported benefits of metformin in pregnant women. According to the results of the MiTy study conducted in Canada and Australia, taking metformin while taking insulin controlled blood sugar levels in pregnant women, reduced weight and lowered the rate of cesarean section during pregnancy. I’m leaving.
Professor Denice Feig of the University of Toronto, Canada, who participated in the MiTy study, said in a commentary on the MOMPOD study: “These findings suggest that although metformin may be useful in reducing the likelihood of delivery at gestational age and In controlling maternal blood sugar, other benefits of metformin may be reduced for some pregnant women. “It shows,” she explained.
Meanwhile, Professor Boggess’ research group plans to conduct a meta-analysis of individual patient data combining data from the MiTy and MOMPOD research.
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