Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy

Terminated

• Conditions: Preterm Birth; Birth Defects; Type 2 Diabetes

• Registration Number: NCT00579150
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-21
• Study Start: 2009-01
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-24
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

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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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome	For each group, primary outcome measure will be assessed among all births, including major birth defects identified during the postnatal period and up to infant age 12 months.	For each group, the primary outcome measure will be percentage of major birth defects-i.e., those that caused significant functional or cosmetic impairment, required surgery, or were life-limiting-among all births, including major birth defects identified during the postnatal period and up to infant age 12 months. For each group, the primary outcome measure will be percentage of major birth defects-i.e., those that caused significant functional or cosmetic impairment, required surgery, or were life-limiting-among all births, including major birth defects identified during the postnatal period and up to infant age 12 months.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measure	For each group, secondary outcome measures will be assessed among all identified pregnancies.	For each group, the secondary outcome measure is to evaluate the percentage of the following outcomes among pregnancies or births in women with type 2 diabetes: Recognized spontaneous abortion (\<20weeks gestation), Stillbirth (death of fetus at \>/= weeks gestation, Preterm birth (\<37 weeks gestation, infant macrosomia (\>4,000 grams), low birth weight infants (\<2,50o grams). To examine any potential impact of breastfeeding on infant growth during the first 4 months of life.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Wilmington, North Carolina, United States