Four co-investigators from UNC will lead a five-year, multicenter study to examine the impact of combined Metformin and insulin therapy on infant outcomes with mothers experiencing type 2 diabetes in pregnancy.
Four co-investigators from UNC will lead a five-year, multicenter study titled Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) to examine the impact of combined Metformin and insulin therapy on infant outcomes with mothers experiencing type 2 diabetes in pregnancy.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development awarded $4.2 million over five years to support MOMPOD.
The multidisciplinary, collaborative project is led by Dr. Kim Boggess, a professor in the Division of Maternal-Fetal Medicine; Dr. Diane Berry, associate professor and Beerstecher-Blackwell Distinguished Term Scholar in the School of Nursing; Dr. Laura Young, assistant professor in the Division of Endocrinology & Metabolism; and Dr. Sonia Davis, a professor in the Department of Biostatistics.
Pregnancy naturally results in an increased resistance to insulin so more glucose can be transferred to energy to fuel the development of the fetus. However, over 100,000 women a year in the United States experience type 2 diabetes during pregnancy, also knowns as gestation diabetes. When this occurs the pancreas is unable to produce enough insulin to manage the amount of glucose that remains in the blood. The presence of type 2 diabetes during pregnancy results in over one-third of pregnancies with an adverse outcome such as premature delivery, infants that are large-for-gestational age, hypoglycemia, hyperbilirubinemia, or birth trauma. Insulin therapy has been the standard for treating type 2 diabetes complicating pregnancy, however, adverse outcomes still exist.
“We are building on the premise that glycemic control is important throughout pregnancy,” Boggess says. “We know from previous research that insulin monotherapy falls short of optimizing outcomes and so we will be studying the effect that the addition of Metformin to insulin has on infant health.”
The drug Metformin is favored over insulin by the American Diabetes Association and the European Association for the Study of Diabetes because it results in less weight gain, fewer hypoglycemic episodes, and is oral rather than injectable. However, Metformin is not currently recommended for treating type 2 diabetes in pregnancy due to a lack of large-scale clinical studies. MOMPOD will address this gap.
“This will be the first and largest trial ever, in the United States, of type 2 diabetes complicating pregnancy,” Boggess says. “The findings are going to potentially define the optimal therapy for these women, and have the potential to change practice.”
Boggess previously conducted a pilot study with 28 women over nine months. The results found 43% of the women randomized to include Metformin in their therapy, also required insulin to manage their gestational diabetes. The remaining women on Metformin had less hypoglycemia than women on insulin. These results encouraged Boggess to pursue funding for the MOMPOD Study Consortium.