Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy
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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 Amylin Pharmaceuticals, Inc. and is managed by Kendle International, Inc. (Kendle). 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 Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy |
- Primary Outcome [ 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.
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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1 Exenatide
Exposure to any form of exenatide during pregnancy for treatment of type 2 diabetes.
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Non-exenatide group
Exposure to non-insulin antidiabetic medication not including exenatide for treatment of pre-existing type 2 diabetes during pregnancy.
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Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Is pregnant and at least 18 years of age at the time of enrollment
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| Contact: Exenatide Pregnancy Registry Call Center | 800-633-9081 | pregnancyregistries@incresearch.com |
| United States, North Carolina | |
| INC Research | Recruiting |
| Wilmington, North Carolina, United States, 28405 | |
| Contact: Exenatide Pregnancy Registry Call Center 800-633-9081 pregnancyregistries@incresearch.com | |
| Principal Investigator: | Vikki Brown, MD | INC Research, LLC |
| Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Angie Graves, Project Director, INC Research |
| ClinicalTrials.gov Identifier: | NCT00579150 History of Changes |
| Other Study ID Numbers: | BCA401 |
| Study First Received: | December 19, 2007 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by INC Research:
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Birth Defects High Risk Pregnancy Type 2 Diabetes |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Congenital Abnormalities Pregnancy in Diabetics Premature Birth Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications Exenatide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013