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Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00579150
First received: December 19, 2007
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

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.


Condition Phase
Birth Defects
Type 2 Diabetes
Preterm Birth
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Primary Outcome [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    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:
  • Secondary Outcome Measure [ Time Frame: For each group, secondary outcome measures will be assessed among all identified pregnancies. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 400
Study Start Date: January 2009
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579150

Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
United States, North Carolina
Research Site Recruiting
Wilmington, North Carolina, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Vikki Brown, MD INC Research
Study Director: Esther Pascual AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00579150     History of Changes
Other Study ID Numbers: D5550C00004, BCA401
Study First Received: December 19, 2007
Last Updated: November 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by AstraZeneca:
Birth Defects
High Risk Pregnancy
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Congenital Abnormalities
Pregnancy in Diabetics
Premature Birth
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014