Four co-investigators from the University of North Carolina at Chapel Hill will lead a five-year, multicenter clinical trial titled “Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD).” MOMPOD will examine the impact of combined Metformin and insulin therapy on infant outcomes with mothers experiencing Type 2 diabetes in pregnancy.
[Photo: More than 100,000 women annually in the U.S. experience Type 2 diabetes during pregnancy. One-third or more of these pregnancies have adverse neonatal outcomes, including premature delivery, birth trauma, hypoglycemia (low blood sugar) at birth, or infants that are large for gestational age. Photo by netdoctor.com (UK)]
The Eunice Kennedy Shriver National Institute of Child Health and Human Development awarded $4.2 million over five years to support MOMPOD.
The multidisciplinary project is co-led by four researchers at UNC: Dr. Sonia Davis, Professor of the Practice of biostatistics at the Gillings School of Global Public Health and director of the Collaborative Studies Coordinating Center, Dr. Kim Boggess, professor in the Division of Maternal-Fetal Medicine in the School of Medicine, Dr. Diane Berry, associate professor and Beerstecher-Blackwell Distinguished Term Scholar in the School of Nursing, and Dr. Laura Young, assistant professor in the Division of Endocrinology & Metabolism in the School of Medicine.
Pregnancy naturally results in a mother’s body experiencing an increased resistance to insulin, which allows more glucose to be transferred into energy to fuel fetal development. Unfortunately, more than 100,000 women per year in the United States experience Type 2 diabetes during pregnancy, in which the pancreas is unable to produce enough insulin to manage the amount of glucose that remains in the blood. More than one-third of pregnancies in mothers with Type 2 diabetes have some type of adverse neonatal outcome, such as premature delivery, hypoglycemia (low blood sugar) at birth, infants that are large-for-gestational age or birth trauma.
Insulin therapy has been the standard for treating Type 2 diabetes during pregnancy, but adverse outcomes still exist. Outside of pregnancy, the drug Metformin is favored over insulin by the American Diabetes Association because it results in less weight gain and fewer hypoglycemic episodes. Metformin currently is not recommended for treating Type 2 diabetes in pregnancy, however, due to a lack of large-scale clinical studies.
The MOMPOD Study Consortium will address this gap with an enrollment goal of 1,200 mothers who will be randomized to receive either Metformin or a placebo in addition to insulin.
“Our aim is to test whether the addition of Metformin during pregnancy will decrease the rate of adverse neonatal outcomes,” Dr. Davis said.
Results from a previous pilot study of Metformin conducted by Dr. Boggess suggest that a combination of Metaformin plus insulin may allow pregnant mothers to better manage their Type 2 diabetes – with fewer episodes of hypoglycemia – than women on insulin alone. These early results encouraged the development of MOMPOD.
“A majority of the maternal-fetal health providers we surveyed believed it should be a treatment continued on through pregnancy, but think it needs the FDA’s blessing,” Dr. Boggess said. “We are eager to help find a better solution than the current insulin-only practice, should MOMPOD’s results prove positive.”
Nine other institutions will collaborate on the multi-site study, including Ohio State University, Columbia University, University of Alabama at Birmingham, University of California at San Diego, University of Mississippi Medical Center, University of Pennsylvania, University of Utah, University of Texas Health Science Center at Houston and University of Texas Medical Branch at Galveston.