NCT03570632 is a Phase 4 clinical trial of Metformin in Diabetes Mellitus, Type 1, sponsored by Maisa N. Feghali, MD.

Who is sponsoring NCT03570632?

NCT03570632 is sponsored by Maisa N. Feghali, MD.

What drugs are being tested in NCT03570632?

Interventions in NCT03570632: Metformin.

What condition does NCT03570632 study?

NCT03570632 studies Diabetes Mellitus, Type 1, Pregnancy in Diabetes.

Is NCT03570632 still recruiting?

NCT03570632 is currently active, enrolled. Last updated 8 January 2026.

Last reviewed 2026-01-08 · How we verify

NCT03570632

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus

Active, enrolled Phase 4 Last updated 8 January 2026

What this trial tests

Phase 4 trial testing Metformin in Diabetes Mellitus, Type 1 in 60 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 July 2019

Primary endpoint
30 October 2025

31 May 2026

Quick facts

Lead sponsor	Maisa N. Feghali, MD
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	60
Start date	8 July 2019
Primary completion	30 October 2025
Estimated completion	31 May 2026
Sites	1 location across United States

Drugs / interventions tested

Metformin (metformin) — full drug profile →

Conditions studied

Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Pregnancy in Diabetes — all drugs for Pregnancy in Diabetes →

Sponsor

Maisa N. Feghali, MD

Who can join

Adults 18 to 50, female only, with Diabetes Mellitus, Type 1 or Pregnancy in Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Although major advancements have been made in improving glycemic management in type 1 diabetes mellitus (DM), women entering pregnancy with type 1 DM continue to be at dramatically increased risk for adverse maternal and neonatal outcomes, including hypertensive disorders of pregnancy (HDP). At present, there is a lack of effective preventive interventions for HDP, which are associated with significant maternal and neonatal morbidity and mortality. Clinical and in vitro data have shown promise for metformin in prevention of HDP in non-diabetic women. Metformin has a reassuring fetal safety profile and has been well studied in type 1 DM outside of pregnancy. The hypothesis to be tested in this application is that compared to usual care, daily oral metformin therapy initiated prior to 20 weeks' gestation in women with type 1 DM reduces the frequency of HDP.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

New Ideas for the Prevention and Treatment of Preeclampsia and Their Molecular Inspirations.
Sakowicz A, Bralewska M, Rybak-Krzyszkowska M, Grzesiak M, et al · · 2023 · cited 28× · PMID 37569476 · DOI 10.3390/ijms241512100
A narrative review of metformin in pregnancy: Navigating benefit and uncertainty.
McEvoy RP, Newman C, Egan AM, Dunne FP. · · 2025 · cited 6× · PMID 40171857 · DOI 10.1111/dom.16361

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

NCT07325461 — Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes · NA · recruiting
NCT07305805 — A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes · Phase 1 · recruiting
NCT06282055 — Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes · recruiting
NCT06325202 — Closed Loop and Education for Hypoglycemia Awareness Restoration · NA · recruiting
NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting

Other Maisa N. Feghali, MD trials

Trials by the same sponsor.

NCT05482789 — Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes · Phase 4 · recruiting
NCT03029702 — Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03570632 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Maisa N. Feghali, MD
Last refreshed: 8 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03570632.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing