Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00579150 · ClinicalTrials.gov registry record
Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy
A clinical trial, sponsored by AstraZeneca.
- Terminated
- Registry status
- 7
- Enrollment target
NCT00579150: Clinical Trial study, sponsored by AstraZeneca.
NCT00579150 is a clinical trial that was terminated before completion, run by AstraZeneca. The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00579150 was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- 7 participants
- Enrollment target
Study 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.
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 l
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-01 |
| Est. Completion | 2016-04 |
Why NCT00579150 stopped before completion
NCT00579150 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 7 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00579150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00579150 about?
NCT00579150 is a clinical study titled "Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy". 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 int...
What is the current status of trial NCT00579150?
This trial is currently terminated. The enrollment target is 7 participants. The study started on 2009-01. Estimated completion is 2016-04.
Who is sponsoring clinical trial NCT00579150?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia