Exenatide Pregnancy Registry

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

Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy (EPR)
Pregnancy registry for women who have been exposed to exenatide or other non-insulin antidiabetic agents.

Why is the Registry important?
Who is eligible to enroll?
Why should I participate?
The Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy (EPR) is a voluntary program established to monitor outcomes of pregnancy in women with type 2 diabetes who have been exposed to exenatide (BYETTA® injection or other formulations of exenatide) or any other non-insulin antidiabetic agents during their pregnancy. There are no adequate and well-controlled studies of pregnant women who were exposed to exenatide (BYETTA® injection) or other non-insulin antidiabetic medicines. BYETTA® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy is a US only registry designed to monitor pregnancies in women with type 2 diabetes. 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 health care provider.
Voluntary enrollment into EPR is through health care 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 - Type 2 Diabetes in Pregnancy is sponsored by Amylin Pharmaceuticals, Inc. and is managed by Kendle International Inc.
Why is the Registry Important?
BYETTA® is approved in the United States as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus (T2DM) who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control.

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:
  • Pregnant and at least 18 years of age
  • Diagnosed with type 2 diabetes prior to becoming pregnant
  • Unknown pregnancy outcome
  • No knowledge of any birth defects from prenatal tests
  • During pregnancy, was exposed to exenatide (BYETTA® or other formulations of exenatide) or other non-insulin antidiabetic medication for diabetes
  • Willing to provide informed consent and permission for medical release of information about the pregnancy
  • 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 exenatide (BYETTA® or other 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 click on the link http://pi.lilly.com/us/byetta-ppi.pdf.
If you are a health care provider:
The Registry is the primary source of information about exposures to any non-insulin antidiabetic medications, including exenatide (BYETTA® or other 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 enrolling and/or referring your patients who are currently pregnant and have been exposed to any non-insulin antidiabetic medications, including exenatide (BYETTA® or other formulations of exenatide), during the pregnancy. To register your patients, please contact the Registry Coordinating Center by calling
1-800-633-9081.

For more information about BYETTA®, please click on the link http://pi.lilly.com/us/byetta-pi.pdf.
The success of the registry depends on the continued participation of health care 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.