Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Diabetes |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2013 |
| Start Date: | August 2008 |
| End Date: | April 2010 |
| Contact: | Ashley Hickman, MD |
| Email: | ahickman@med.unc.edu |
| Phone: | 919-966-1601 |
Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)
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 NPH
insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is
equivalent to insulin in these women.
Inclusion Criteria:
- Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric
clinics and planning delivery at UNC Women's Hospital
- Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or
dietary control
- Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3
hour glucose challenge testing using the national diabetes data group (NDDG)criteria
- Less than 24 weeks at study enrollment
- Singleton or twin pregnancy
- English or Spanish speaking
- Able to give informed consent
Exclusion Criteria:
- End organ complications of diabetes (retinopathy, renal insufficiency, etc.)
- Prior need for insulin for glycemic control
- History of diabetic ketoacidosis (DKA) or hyperosmolar state
- Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin
- Kidney or liver disease
- Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension
controlled on one medication, well controlled asthma, and well controlled thyroid
disease are not excluded.
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