Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy (Exenatide)

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Wilmington, North Carolina, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Is pregnant and at least 18 years of age at the time of enrollment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome Measure	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.	For each group, secondary outcome measures will be assessed among all identified pregnancies.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Vikki Brown, MD, Syneos Health; Study Director: Esther Pascual, AstraZeneca

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 19, 2007
• First Posted (Estimate): December 21, 2007

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: May 24, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Birth Defects; High Risk Pregnancy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Diabetes Mellitus; Diabetes Mellitus, Type 2; Congenital Abnormalities; Premature Birth; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: D5550C00004; BCA401 (Other Identifier: INC Research)