Status:
COMPLETED
Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
WakeMed Health and Hospitals
Conditions:
Non Insulin Dependent Diabetes
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00835861
Start Date
August 1 2008
End Date
April 1 2010
Last Update
April 25 2017
Active Locations (1)
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1
University of North Carolina Hospitals Obstetric Clinics
Chapel Hill, North Carolina, United States, 27599