Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
Many women come into pregnancy with diabetes that is controlled with either Metformin or diet
control; however, the current standard of care for the treatment of preexisting diabetes in
pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic
control, and has been used in pregnancy for other indications without adverse maternal or
fetal outcomes. What remains unproven is the ability of Metformin to adequately control
glucose in women during pregnancy.
Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by
either diet or an oral agent and women who are found to have an abnormal glucose challenge
test at less than 20 weeks to either standard treatment with weight based Regular and neutral
protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide
glycemic control that is equivalent to insulin in these women.