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Biguanide

Metformin for Pre-eclampsia Prevention in Type 1 Diabetes

Phase 4
Recruiting
Led By Maisa N Feghali, MD
Research Sponsored by Maisa N. Feghali, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with type 1 DM prior to pregnancy.
Pregnant women 18-50 years 12 0/7 and 19 6/7 weeks of gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery/end of pregnancy
Awards & highlights

Study Summary

This trial will test whether metformin can help prevent hypertensive disorders of pregnancy in women with type 1 diabetes.

Who is the study for?
This trial is for pregnant women aged 18-50 with type 1 diabetes, between 12 and just under 20 weeks of gestation. It's not suitable for those with multiple pregnancies, kidney issues, significant protein in urine, liver disease, inflammatory bowel disease, major blood disorders or known metformin allergies.Check my eligibility
What is being tested?
The study tests if taking metformin before the 20th week of pregnancy can reduce high blood pressure-related complications compared to usual care in women with type 1 diabetes. Metformin is a medication typically used to manage diabetes and has been shown safe outside pregnancy.See study design
What are the potential side effects?
Metformin may cause side effects like nausea, diarrhea, stomach pain and loss of appetite. Rarely it could lead to a serious condition called lactic acidosis especially if there are kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with type 1 diabetes before becoming pregnant.
Select...
I am pregnant, between 18 to 50 years old, and in my second trimester.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery/end of pregnancy
This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery/end of pregnancy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of hypertensive disorders of pregnancy
Secondary outcome measures
Birthweight
Home glucose levels throughout pregnancy
Neonatal morbidity
Other outcome measures
Gestational weight gain
Neonatal body composition
Umbilical cord c-peptide
+1 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MetforminExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Maisa N. Feghali, MDLead Sponsor
2 Previous Clinical Trials
67 Total Patients Enrolled
Maisa N Feghali, MDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
54 Total Patients Enrolled

Media Library

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT03570632 — Phase 4
Gestational Diabetes Research Study Groups: Usual care, Metformin
Gestational Diabetes Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT03570632 — Phase 4
Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03570632 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~7 spots leftby Dec 2024