Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy

NCT ID: NCT00579150

Last Updated: 2016-05-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2016-04-30

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.

Conditions

Birth Defects; Type 2 Diabetes; Preterm Birth

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exenatide

Exposure to any form of exenatide during pregnancy for treatment of type 2 diabetes. Patients also taking Insulin may be included, though only as part of a combination treatment.

No interventions assigned to this group

Non-exenatide group

Exposure to non-insulin antidiabetic medication not including exenatide for treatment of pre-existing type 2 diabetes during pregnancy. Patients also taking Insulin may be included, though only as part of a combination treatment.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vikki Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Syneos Health

Esther Pascual

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Research Site

Wilmington, North Carolina, United States

Countries

United States

Other Identifiers

BCA401

Identifier Type: OTHER

Identifier Source: secondary_id

D5550C00004

Identifier Type: -

Identifier Source: org_study_id