Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy
This is an observational, prospective cohort study describing pregnancy outcomes in women with pre-existing (prior to pregnancy) type 2 diabetes who have been exposed to exenatide (BYETTA) during pregnancy. The pregnancy registry will compare the occurrence of the pregnancy outcomes of interest with those collected from a prospective group of women with pre-existing type 2 diabetes who have been exposed to one or more antidiabetic medications other than exenatide during pregnancy. Insulin exposures are acceptable in both groups but must be in addition to one or more other antidiabetic medications in the non-exenatide group.
The primary study objective is to evaluate the percentage of major birth defects (i.e., those that caused significant functional or cosmetic impairment, required surgery, or were life-limiting) following use of exenatide (BYETTA) during pregnancy for treatment of type 2 diabetes compared to the percentage of major birth defects following use of one or more antidiabetic medications other than exenatide during pregnancy for treatment of type 2 diabetes.
The secondary objectives of the Exenatide Pregnancy Registry are to evaluate the percentage of other adverse pregnancy outcomes (e.g., spontaneous abortion, stillbirth, preterm birth) and any potential impact of exenatide (BYETTA) use during breastfeeding among pregnancies or births in women who used exenatide for pre-existing type 2 diabetes:
This study is being conducted in the United States (US). Enrollment in the Registry is voluntary. The Exenatide Pregnancy Registry is sponsored by Amylin Pharmaceuticals, Inc. and is managed by Kendle International, Inc. (Kendle). The scientific conduct and analysis of the Registry is overseen by a Registry Review Committee (RRC) consisting of experts in maternal and fetal medicine, teratology/genetics, epidemiology, type 2 diabetes in pregnancy and/or pediatrics.
Status: Recruiting (Phase 4). Started on December 1st, 2007.
Enrollment: 400 subjects
Study Type: Observational
Study Design:
- Observational Model: Cohort
- Time Perspective: Prospective
Conditions:
Interventions:
Eligibility
Inclusion Criteria:
The subjects must meet the following eligibility criteria for participation in the registry:
Is pregnant and at least 18 years of age at the time of enrollment
Had a diagnosis of type 2 diabetes prior to pregnancy
Does not know the pregnancy outcome at the time of enrollment
Has no knowledge of any existing structural or chromosomal defects detected on a prenatal test prior to enrollment
Had been exposed to exenatide (for exenatide group) or a non-insulin antidiabetic medication other an exenatide (for the non-exenatide group) on or after the first day of the last menstrual period (insulin use will be allowed for both groups)
Is willing and able to provide informed 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)
Is able to understand spoken English or Spanish
- Gender
Female
- Mininum Age
N/A
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: Kendle International
Authority: United States: Institutional Review Board
Locations
-
Kendle International, Inc.
Wilmington
North Carolina
28405
United States
Officials
Vikki Brown, MD (Principal Investigator, Kendle International, Inc.)
Lisa Porter, MD (Study Director, Amylin Pharmaceuticals, Inc.)
Sponsors
Kendle International (Lead Sponsor)
Amylin Pharmaceuticals, Inc. (Collaborator)
References
None.
Links
- Date Verified
- May 1st, 2010
- First Received
- May 25th, 2010
- Last Changed
- May 25th, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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