# Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD)

> **NIH NIH R01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2021 · $652,208

## Abstract

Abstract
Over 100,000 pregnant women with overt type 2 diabetes (T2DM) give birth in the
United States every year. Strict maternal glycemic control is the key to optimizing infant
outcomes. Medical treatment of overt T2DM in pregnancy is generally restricted to
insulin as data on the safety and efficacy of oral hypoglycemic agents for overt T2DM is
limited. However, over one-third infants born to women with overt T2DM experience an
adverse outcome such as premature delivery, large-for-gestational age (LGA),
hypoglycemia, hyperbilirubinemia, or birth trauma, suggesting that current treatment
regimens fall short of optimizing outcomes. We believe that further research is needed to
identify better strategies to reduce neonatal complications of overt T2DM in pregnancy.
Metformin is the pharmacologic treatment of choice for overt T2DM outside of pregnancy.
Metformin is favored over insulin because it results in less weight gain, fewer
hypoglycemic episodes, and is oral rather than injectable. Metformin’s mechanism of
action directly counteracts the insulin resistance characteristic of T2DM. Metformin is not
recommended for treatment of T2DM complicating pregnancy, mainly because there are
no large clinical studies examining its use in this context. Research is needed to address
this knowledge gap. Our long-range goal is to optimize maternal and infant outcomes in
overt T2DM complicating pregnancy. The objective of this proposal is to study the
efficacy and safety of adjuvant metformin for treatment of T2DM among pregnant
women receiving insulin therapy. Our central hypothesis is that compared to insulin
alone, insulin plus metformin will result in improved neonatal outcomes. We will test this
hypothesis byprospectively randomizing 1334 pregnant women with overt T2DM to
insulin plus placebo therapy versus insulin plus metformin to accomplish the following
specific aims: 1: To measure the effect of insulin/metformin on composite adverse
neonatal outcome (perinatal mortality-miscarriage; stillbirth or neonatal death; preterm
delivery, neonatal hypoglycemia, hyperbilirubinemia, and/or birth trauma); infant birth
weight and fat mass, among pregnant women with T2DM.; 2: To measure safety of
insulin/metformin use among pregnant women with overt T2DM; and 3: To quantify
gestational weight gain (GWG) and satisfaction with therapy among women treated with
metformin. Successful completion of this proposal will result in high quality contemporary
evidence for management of overt T2DM complicating pregnancy to improve neonatal
outcomes.

## Key facts

- **NIH application ID:** 10112753
- **Project number:** 5R01HD086139-05
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** DIANE C BERRY
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $652,208
- **Award type:** 5
- **Project period:** 2016-09-23 → 2022-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10112753

## Citation

> US National Institutes of Health, RePORTER application 10112753, Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) (5R01HD086139-05). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10112753. Licensed CC0.

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