Exenatide Pregnancy Registry

Pregnancy Registry, Diabetes, BYETTA, byetta, Type 2 Diabetes

Information Collected

How is Data Collected by the Registry?
The Registry will collect patient medical information from participating patients and their healthcare providers. No study medication will be given and participation in the Registry will not influence or interfere with the treatment plan recommended by the patient's healthcare provider. For patients who enroll in the Registry, patient medical information may be collected by phone or through the Data Forms downloaded from the Registry website. Information will be collected at 6 different times depending on when in your pregnancy you enroll in the Registry:
  • at the time of registration
  • at the end of the second trimester
  • at the end of pregnancy
  • Pediatrician 4 and 12 month follow up
Information that will be collected:
  • Patient demographics
  • Diabetes and medical history
  • Antidiabetic medication exposure information
  • Maternal status and prenatal testing information
  • History of glucose control
  • Pregnancy outcome information
  • Breastfeeding information
  • Neonatal wellness and growth information
  • Additional information may be requested from health care providers should any adverse pregnancy outcomes occur
How is Data Analyzed and Reported?
The Registry data will be collected by the Registry Coordinating Center over the phone or by using the Data Forms that were completed by the participating patient, the patient's health care provider, or the Registry staff on behalf of the participating patient.

A Registry Review Committee will oversee the data collection, data analysis, and presentation of results. The committee members include medical professionals from the Sponsor of the Registry and independent experts from the scientific and medical community. The Registry Review Committee will provide guidance on study progress and will review and provide interpretation of cumulative data on a regular basis.