Exenatide Pregnancy Registry

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

Exenatide Pregnancy Registry (EPR)
Pregnancy Registry for women who have been exposed to immediate release formulation of exenatide (BYETTA®) or other non-insulin antidiabetic agents on or after the first day of their last menstrual period, or women who were exposed to an extended formulation of exenatide (Bydureon®) within 8 weeks or after the first day of the last menstrual period.

Why is the Registry important?
Who is eligible to enroll?
Why should I participate?
The Exenatide Pregnancy Registry (EPR) is a voluntary program established to monitor outcomes of pregnancy in women with Type 2 diabetes who have been exposed to all formulations of exenatide including BYETTA® and Bydureon®, or any other non-insulin antidiabetic agents during their pregnancy. The Registry also follows the infant through the first 12 months of life. There are no adequate and well-controlled studies of pregnant women who were exposed to exenatide or other non-insulin antidiabetic medicines. All formulations of exenatide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The Exenatide Pregnancy Registry is a Registry designed to monitor pregnancies in women with Type 2 diabetes. The Registry also follows the infant through the first 12 months of life. This is a voluntary, prospective, observational registration and follow-up study. 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.
Voluntary enrollment into EPR is through healthcare providers or directly by the patient. If you are interested in the Registry and want more information, click on contact us or call us at 1-800-633 9081.
The Exenatide Pregnancy Registry is sponsored by Amylin Pharmaceuticals, Inc. and is managed by INC Research, LLC.
Why is the Registry Important?
Exenatide is approved in the United States as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.

During the development of exenatide, pregnant women were actively excluded from clinical trials. As a result, there is limited human data on the fetal effects of in utero exposure to exenatide. The lack of data on exenatide pregnancy exposures and their outcomes make this Registry an essential program to study prenatal exposures to exenatide in women with Type 2 diabetes.

This Registry is an essential component of the ongoing risk management program and epidemiologic studies on the safety of this product. Registry data supplement other sources of data and as data accrue, may assist clinicians and patients in weighing risks of exenatide and other antidiabetic exposure in pregnancy.
Who is Eligible to Enroll in the Registry?
A woman may enroll in the Registry if she meets the following criteria:
  • Participant is pregnant and at least 18 years of age at the time of enrollment
  • Participant had a diagnosis of type 2 diabetes prior to pregnancy
  • Participant does not know the pregnancy outcome at the time of enrollment
  • Participant has no knowledge of any existing structural or chromosomal defects detected on a prenatal test prior to enrollment
  • Participant has been exposed to an immediate release formulation of exenatide (e.g. BYETTA®) or a non-insulin antidiabetic medication other than exenatide on or after the first day of the last menstrual period (insulin use will be allowed for both groups).
    OR
  • Participant has been exposed to an extended release formulation of exenatide (e.g. BYDUREON®) within 8 weeks of the first day of the last menstrual period
  • Participant is willing and able to provide informed (written or verbal) consent and an authorization for the pregnancy registry to contact the obstetric HCP, diabetes HCP, and the infant’s pediatric HCP (and complete contact information for these practitioners, if different, and if available)
  • Participant is able to understand spoken English or Spanish
Why Should I Participate?
If you are a pregnant woman with Type 2 diabetes:
Your participation may help other patients like you in the future. The results of this study may increase knowledge about the effects of exposure to all formulations of exenatide and other antidiabetic medications during pregnancy. The results of this study may help doctors and patients in weighing the risks and/or benefits of exenatide exposure during pregnancy. You will also receive a gift card for taking part in the Exenatide Pregnancy Registry. If you are interested in participating in the Registry, please contact us at
1-800-633-9081.

For more information about BYETTA®, please visit www.byetta.com.

For more information about BYDUREON®, please visit www.bydureon.com.
If you are a healthcare provider:
The Registry is the primary source of information about exposures to any non-insulin antidiabetic medications, including all formulations of exenatide, during pregnancy. Your participation will help advance this public health initiative. Information from this Registry, supplemented with other sources of data, may aid clinicians and patients in weighing the risks and/or benefits of exenatide exposure during pregnancy.

Please consider initiating enrollment and/or referring your patients who are currently pregnant and have been exposed to any non-insulin antidiabetic medications, including all formulations of exenatide, during the pregnancy. To begin the registration process for your patients, please contact the Registry Coordinating Center by calling
1-800-633-9081.

For more information about BYETTA®, please visit www.byetta.com.

The success of the Registry depends on the continued participation of healthcare providers and pregnant women with Type 2 diabetes for registration and follow-up. The support and contributions of patients and providers who have participated are greatly appreciated.