Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide
Status:
Withdrawn
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
Diabetes is more likely to occur during pregnancy. When present only in pregnancy it is
called gestational diabetes, and it places both mom and baby at risk for complications.
Glyburide is one of the currently used treatments for diabetes during pregnancy. This drug is
a medication taken by mouth that decreases sugar levels in the blood. It is known to decrease
the risk of complications linked to diabetes in pregnancy. Recent studies in pregnancy have
described a difference in the way and how well the drug works compared to when used outside
of pregnancy.
Oral blood sugar lowering agents are approved by the Food and Drug Administration (FDA) to
lower blood sugar in non-pregnant subjects with diabetes. No oral (taken by mouth)
blood-sugar lowering agents are FDA approved for use in pregnancy. Although Glyburide is not
FDA approved for this use, it is the most commonly used oral blood sugar lowering agent in
pregnancy.
This research study will help us learn more about the variations in blood sugar levels in
women with diabetes in pregnancy who are taking glyburide and how changes in the timing of
when the glyburide is taken would affect blood glucose levels. The goals of this study are:
- To find the how glucose changes throughout the day in women with diabetes in pregnancy
receiving glyburide
- To learn the effect of changing the time of taking glyburide on glucose levels
- To learn the effect of changing the time between glyburide doses on glucose levels
- To see if insulin is secreted the same throughout the day in response to a morning dose
of glyburide.