This study is being done because pregnant women with Type 2 and early diagnosed diabetes have an increased risk for delivering a large baby, a baby who has medical problems such as low blood sugar at birth, and/or a baby that may be injured during birth due to his/her size. The only medicine that is approved by the FDA to treat diabetes in pregnancy is insulin, even if a pregnant woman previously treated her diabetes with oral medication or pills.
The study drug, Metformin, is a pill used to treat Type 2 diabetes and is the treatment of choice for non-pregnant people with Type 2 diabetes. Metformin is preferred over insulin because it results in less weight gain and fewer episodes and symptoms of low blood sugar. Metformin has been used in early pregnancy for women with polycystic ovarian syndrome and later in pregnancy to treat gestational diabetes. These studies show that there appear to be no unfavorable immediate effects of Metformin on the mother or her baby by the long-term effects are still unknown. However, there are very few studies testing the use of Metformin for the treatment of Type 2 or early diagnosed diabetes in pregnancy.
- You are a pregnant woman who is between the ages if 18-45 years
- You are not pregnant with twins or multiples (singleton pregnancy)
- Diagnosed with Type 2 Diabetes Mellitus (T2DM) [preexisting T2DM requiring medical treatment] or diagnosed with gestational diabetes early in your pregnancy (less than 22 weeks and 6 days).
- Willingness to use insulin and Metformin only, no other diabetes medical therapy is permitted while on the study
- You are less than 23 weeks pregnant
Qualified participants will be compensated up to $50 for their time and travel.
Whom do I contact for more information?
To find out more information and to learn if you are qualified to participate, please call the Pregnancy Research Group at 503-494-8748.