Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies, Diabetes |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/26/2016 |
| Start Date: | January 2009 |
| End Date: | April 2016 |
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 any
formulation of exenatide 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 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 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 AstraZeneca and is managed by
INC Research, LLC. 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.
with pre-existing (prior to pregnancy) type 2 diabetes who have been exposed to any
formulation of exenatide 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 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 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 AstraZeneca and is managed by
INC Research, LLC. 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.
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 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
- 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
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