NCT02394158 (PRoDroME) is a Phase 4 clinical trial of Metformin in Gestational Diabetes Mellitus, sponsored by Imperial College London.

Who is sponsoring NCT02394158?

NCT02394158 is sponsored by Imperial College London.

What drugs are being tested in NCT02394158?

Interventions in NCT02394158: Metformin, placebo.

What condition does NCT02394158 study?

NCT02394158 studies Gestational Diabetes Mellitus.

Is NCT02394158 still recruiting?

NCT02394158 is currently status unknown. Last updated 13 August 2019.

Last reviewed 2019-08-13 · How we verify

NCT02394158: PRoDroME

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

Preventing Recurrent Gestational Diabetes With Metformin

Status unknown Phase 4 Last updated 13 August 2019

What this trial tests

Phase 4 trial testing Metformin in Gestational Diabetes Mellitus in 112 participants. Status unknown.

Timeline

27 January 2015

Primary endpoint
30 September 2019

30 September 2019

Quick facts

Lead sponsor	Imperial College London
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	112
Start date	27 January 2015
Primary completion	30 September 2019
Estimated completion	30 September 2019
Sites	2 locations across United Kingdom

Drugs / interventions tested

Metformin (metformin) — full drug profile →
placebo

Conditions studied

Gestational Diabetes Mellitus — all drugs for Gestational Diabetes Mellitus →

Sponsor

Imperial College London

Who can join

Adults 18 to 45, female only, with Gestational Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent gestational diabetes mellitus recurring in previously affected pregnancies.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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 Gestational Diabetes Mellitus

Currently open trials in the same condition.

NCT06997835 — The Role of Early Nursing Intervention in the High-risk Population of Gestational Diabetes · NA · active not recruiting
NCT06648174 — The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus · NA · recruiting
NCT06436326 — The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes · NA · recruiting
NCT05852054 — Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP) · Phase 3 · active not recruiting
NCT05800509 — Gestational Diabetes and Perinatal Depression: an Intervention Program · NA · recruiting

Other Imperial College London trials

Trials by the same sponsor.

NCT06035861 — Endothelial Cell Activation and Total Pulmonary Resistance in PAH · NA · not yet recruiting
NCT07397455 — Development of a Controlled Human Infection Model for Assessment of SARS-CoV-2 Omicron Subvariants · Phase 1 · not yet recruiting
NCT07422532 — A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing · NA · not yet recruiting
NCT07389031 — Maralixibat for Intrahepatic Cholestasis of Pregnancy · Phase 2 · not yet recruiting
NCT07358897 — Gender Affirming Hormone Therapy and Immune Function in Trans Individuals - The GIFT Study · not yet recruiting

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 NCT02394158 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Imperial College London
Last refreshed: 13 August 2019

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/NCT02394158.

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