Amylin Pharmaceuticals, Inc. has developed a pregnancy registry to study the outcome of pregnancies 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 medications during pregnancy (at any time since the first day of the last menstrual period through the end of pregnancy). The Registry is being conducted in the United States and managed by Kendle International, Inc., a contract research organization, on behalf of Amylin.
There are no adequate and well-controlled studies of pregnant women who were exposed to exenatide, (BYETTA® injection or other formulations of exenatide) or any other non-insulin antidiabetic medicines. BYETTA® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This Registry is a proactive undertaking by Amylin to evaluate the safety of exenatide use during pregnancy. 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.
If you are a health care provider, you may be aware of women with type 2 diabetes who are currently pregnant and are or have been exposed to exenatide or other non-insulin antidiabetic medications during pregnancy. These pregnant women are encouraged to voluntarily enroll in the Registry before the outcomes of pregnancy are known. 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. To enroll or get more information please contact the Registry Coordinating Center at:
Exenatide Pregnancy Registry – Type 2 Diabetes in Pregnancy
Phone: 1-800-633-9081
Email: click here
For additional information about BYETTA® please click on the following link www.BYETTA.com.
We thank you in advance for your time and contribution and welcome any questions you may have regarding the Registry.