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Metformin for Pre-eclampsia Prevention in Type 1 Diabetes
Study Summary
This trial will test whether metformin can help prevent hypertensive disorders of pregnancy in women with type 1 diabetes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT02002221Trial Design
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Who is running the clinical trial?
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- I do not have severe kidney, liver, bowel, or major blood disorders.You have had a bad reaction to metformin before.There are signs of a major birth defect or genetic condition in the baby on the ultrasound.I was diagnosed with type 1 diabetes before becoming pregnant.I am pregnant, between 18 to 50 years old, and in my second trimester.
- Group 1: Usual care
- Group 2: Metformin
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants have been selected to participate in this research experiment?
"Indeed, the data available on clinicaltrials.gov confirms that this medical study is still gathering participants. It was first launched on July 8th 2019 and last updated November 3rd 2022, with 60 patients being sought from a single site."
Does the research protocol for this trial include participants over 40?
"The parameters for participation in this trial mandate that the age range must be between 18 years old and 50 years old."
Do I meet the criteria for inclusion in this clinical investigation?
"To partake in this diabetes study, participants must have a documented autoimmune disorder and be between 18-50 years old. A cohort of 60 individuals is needed for the trial to commence."
What prior research has been conducted with Metformin?
"Currently, 170 studies are running on Metformin with 43 of those in Phase 3. While Pittsburgh is the primary centre for these trials, there are 1903 other sites conducting research into this potential treatment."
How is Metformin typically employed to improve a patient's condition?
"Metformin is the standard treatment for exercise, and it also has applications in treating type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."
Are there any opportunities for participation in this clinical experiment?
"Clinicaltrials.gov currently lists this trial as recruiting, with the initial posting on July 8th 2019 and updated information from November 3rd 2022."
Is Metformin officially sanctioned by the FDA for medical use?
"Our assessment of Metformin's safety merits a score of 3, as this is a Phase 4 trial that has been granted approval."
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