Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)

Summary

Purpose: The objective of this proposal is to study the safety and efficacy of metformin added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women. Participants: 950 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S. clinical centers Procedures (methods): Pregnant women with T2DM between 10 weeks and 22 weeks 6 days and a singleton fetus will be randomized to double-blinded insulin/placebo versus insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical visits; blood draw at 24-30 weeks, newborn anthropometric measurements at less than 72 hours of life. Maternal and infant outcomes will be chart abstracted.

Timeline

Start

2017-05-25

Primary completion

2022-06-15

Completion

2022-06-15

Outcome

Outcome not reported

Stopped: “Recommendation by the DSMB that the study be stopped for futility”

Publications

• Patel M, Battarbee AN, Refuerzo JS, Zork N, Eichelberger K, Ramos GA, Olson G, Durnwald C, Landon MB, Aagaard KM, Wallace K, Scifres C, Rosen T, Mulla W, Valent A, Longo S, Boggess KA. Association Between Metformin Use in Early Gestational or Type 2 Diabetes in Pregnancy and Preterm Preeclampsia. Obstet Gynecol. 2024 Nov 1;144(5):733-739. doi: 10.1097/AOG.0000000000005720. Epub 2024 Sep 5.
• Boggess KA, Valint A, Refuerzo JS, Zork N, Battarbee AN, Eichelberger K, Ramos GA, Olson G, Durnwald C, Landon MB, Aagaard KM, Wallace K, Scifres C, Rosen T, Mulla W, Valent A, Longo S, Young L, Marquis MA, Thomas S, Britt A, Berry D. Metformin Plus Insulin for Preexisting Diabetes or Gestational Diabetes in Early Pregnancy: The MOMPOD Randomized Clinical Trial. JAMA. 2023 Dec 12;330(22):2182-2190. doi: 10.1001/jama.2023.22949.
• Berry DC, Thomas SD, Dorman KF, Ivins AR, de Los Angeles Abreu M, Young L, Boggess K. Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study. BMC Pregnancy Childbirth. 2018 Dec 12;18(1):488. doi: 10.1186/s12884-018-2108-3.

Drugs

Indications