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Insulin
Insulin Glargine vs NPH for Diabetes in Pregnancy
Phase 3
Recruiting
Led By Joana Lopes Perdigao, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient requiring initiation of insulin therapy for Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus in pregnancy
At least 18 years old
Must not have
Receiving insulin through an insulin pump
Those under the age of 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at delivery
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial aims to compare two different types of insulin, Glargine and NPH, commonly used to manage diabetes during pregnancy. They want to see how these insulins work and compare their effectiveness
Who is the study for?
This study is for pregnant individuals with Type 2 Diabetes or Gestational Diabetes needing insulin. Participants should be those who haven't had adequate studies on the use of Glargine during pregnancy, as current practices vary and NPH insulin is commonly used despite its drawbacks.
What is being tested?
The trial aims to compare two types of insulin: Glargine and NPH. It's designed to see which one is better for managing diabetes in pregnancy, considering that outside of pregnancy, Glargine tends to cause fewer low blood sugar episodes than NPH.
What are the potential side effects?
Possible side effects from both Insulin Glargine and NPH include low blood sugar episodes (hypoglycemia), which can cause symptoms like dizziness, sweating, confusion, and in severe cases unconsciousness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need to start insulin for diabetes during my pregnancy.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I use an insulin pump for my diabetes management.
Select...
I am under 18 years old.
Select...
I am allergic to insulin.
Select...
My diabetes is managed with diet or oral medications.
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I have been diagnosed with Type 1 Diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hypoglycemia
Secondary study objectives
Large for Gestational Age
Shoulder dystocia
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Insulin GlargineActive Control1 Intervention
Insulin Glargine dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.
Group II: Insulin NPHActive Control1 Intervention
Insulin NPH dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.
Find a Location
Who is running the clinical trial?
Loyola UniversityLead Sponsor
160 Previous Clinical Trials
31,296 Total Patients Enrolled
Joana Lopes Perdigao, MDPrincipal InvestigatorLoyola University
1 Previous Clinical Trials