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 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®). The Registry also follows the infant through the first 12 months of life. The Registry is being conducted in the United States and managed by INC Research, LLC, a contract research organization, on behalf of Amylin.
There are no adequate and well-controlled studies of pregnant women who were exposed to exenatide, or any other non-insulin antidiabetic medicines. Exenatide 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 healthcare 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 healthcare provider. To enroll or get more information please contact the Registry Coordinating Center at:
We thank you in advance for your time and contribution and welcome any questions you may have regarding the Registry.