Gestational DiabetesPhase 3EMERGENCT02980276
RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects
A Phase 3 study testing Metformin Hydrochloride in people with Gestational Diabetes, run by National University of Ireland, Galway, Ireland at 2 sites in Ireland.
Trial summary
The overall objective of the EMERGE trial is to determine whether metformin + usual care, compared to placebo + usual care (introduced at the time of initial diagnosis of GDM), reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive maternal weight gain; c) maternal and neonatal… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Metformin Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 535 participants
- Where
- 2 sitesIreland
- Study dates
- 6 Jun 2017to 13 Apr 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Willing and able to provide written informed consent
- Participants aged 18-50
- Pregnancy gestation up to 28 weeks (+ 6 days) confirmed by positive pregnancy test
- Singleton pregnancy as determined by scan
- Positive diagnosis of Gestational Diabetes Mellitus on a Oral Glucose Tolerance Test (OGTT) according to the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria if any one of the following are achieved: i) Fasting glucose >/= 5.1mmol/l and <7mmol/l, or ii) 1 hour post glucose load of >/=10mmol/l, or iii) 2 hour post glucose load of >/=8.5 mmol/l and <11.1mmo/l
- Resident in the locality and intending to deliver within the trial site
Who cannot join
- Participants who have an established diagnosis of diabetes (Type 1, Type 2, Monogenic or secondary)
- Participants with a fasting glucose > 7mmol/l or a 2h value > 11.1 mmol/l
- Multiple pregnancies (twins, triplets etc.) as determined by scan
- Known intolerance to metformin
- Known contraindication to the use of metformin which include: i) renal insufficiency (defined as serum creatinine of greater than 130 µmol/L or creatinine clearance <60 ml/min), ii) moderate to severe liver dysfunction (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, iii) shock or sepsis, and iv) previous hypersensitivity to metformin
- Major congenital malformations or an abnormally deemed unsuitable for metformin by the site PI or attending consultant
Show all 13Show fewer
- Known small for gestational age (Small for gestational age (SGA) refers to foetal growth less than the 10th percentile (RCOG, 2014), or if foetal growth is deemed unsatisfactory by the treating obstetrician)
- Known gestational hypertension or pre-eclampsia or ruptured membranes
- Participants who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
- Participants with significant gastrointestinal problems such as severe vomiting, Crohn's disease or colitis which will inadvertently affect absorption of the study drug
- Participants with congestive heart failure or history of congestive heart failure
- Participants with serious mental illness which would affect adherence to study medication or compliance with study protocol in the opinion of the investigator
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Portiuncula University Hospital
Ballinasloe, Galway
University Hospital Galway
Galway
About this study
Official title: A Randomised Placebo Controlled Trial of the Effectiveness of Early MEtformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects (EMERGE)
The overall objective of the EMERGE trial is to determine whether metformin + usual care, compared to placebo + usual care (introduced at the time of initial diagnosis of GDM), reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive maternal weight gain; c) maternal and neonatal morbidities and, d) cost of treatment for women with Gestational Diabetes Mellitus.
- Conditions
- Gestational Diabetes
- Being tested
- Metformin Hydrochloride, Placebo
- Keywords
- Gestational Diabetes, Diabetes, Pregnancy
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin HydrochlorideDrug
Women randomised to the metformin group will receive metformin 500mg once daily, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of 2500mg Metformin daily (5 tablets) or maximum tolerated dose, in addition to usual care (exercise and MNT), and taken until delivery.
PlaceboOther
Women randomised to the placebo group will receive 1 placebo tablet once daily, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of five placebo tablets daily, in addition to usual care (exercise and MNT), and taken until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Participants randomised to the treatment arm will receive active metformin in addition to standard care. Metformin tablets will be titrated according to a dosing schedule to achieve the pre-specified glucose targets. Tablets will be in 500mg doses and will commence at 1 tablet per day (500mg) increasing to a maximum of 5 tablets per day (2500mg). Receives: Drug: Metformin Hydrochloride |
| Control | Placebo comparator | Participants randomised to the placebo arm will receive placebo in addition to standard care. Placebo will be titrated according to the dosing schedule to achieve the pre-specified glucose targets. Placebo tablets will commence at 1 tablet per day and will be increased to a maximum of 5 tablets per day over 10 days as with the treatment group. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Composite Outcome
The primary efficacy outcome was achieved if any participant experienced:
- Insulin initiation
- Fasting glucose value >5.1 mmol/l at 32weeks or 38 weeks gestation.
Measured: Enrolment through delivery, an average of 16 weeks.
Insulation of Insulin
Initiation of insulin treatment at any time up to delivery.
Measured: Enrolment through delivery, an average of 16 weeks.
Secondary outcomes (32)
Time to Insulin Initiation
Time to Insulin Initiation, from date of randomization until the date of delivery.
Measured: Time to Insulin Initiation, from date of randomization until the date of delivery, an average of 16 weeks..
Insulin Initiated
Whether or not insulin was initiated at any time during the study.
Measured: Enrolment through delivery, an average of 16 weeks.
Fasting Hyperglycemia
Number of women with fasting hyperglycemia at 32wks or at 38wks gestation.
Measured: Measured at 32 and 38 weeks' gestation.
Insulin Dose Required
Insulin dose required in any participant requiring insulin.
Measured: Enrolment through delivery, an average of 16 weeks.
Gestational Weight Gain
Change in weight (kg) from randomization until last visit before delivery
Measured: Enrolment through delivery, an average of 16 weeks.
Postpartum Impaired Fasting Glucose
Impaired fasting glucose at 12 weeks postpartum
Measured: 12 weeks post-partum
Postpartum Impaired Glucose Tolerance
Measured: 12 weeks postpartum
Postpartum Metabolic Syndrome
Measured: 12 weeks postpartum
Gestational Age at Delivery
Measured: At delivery, an average of 16 weeks after enrolment
Mode of Delivery - Cesarian Delivery
Delivered by Cesarian section.
Measured: At delivery, an average of 16 weeks after enrolment
Mode of Delivery - Emergency Cesarian Section
Among those having cesarian section, count of emergency procedures.
Measured: At delivery, an average of 16 weeks after randomization.
Mode of Delivery - Induced
Labor induced.
Measured: At time of labor, an average of 16 weeks after enrolment.
Maternal Morbidity - Pregnancy-induced Hypertension
Measured: From enrolment through 6 weeks postpartum, an average of 22 weeks.
Maternal Morbidity - Pre-eclampsia
Pre-eclampsia diagnosed during study participation
Measured: Enrolment through 6 weeks postpartum, an average of 22 weeks.
Maternal Morbidity - Antepartum Hemorrhage
Any vaginal bleeding prior to delivery
Measured: From enrolment through delivery, an average of 16 weeks.
Maternal Morbidity - Postpartum Hemorrhage
Measured: From delivery through 6 weeks postpartum.
Birthweight
Measured: At birth
Neonatal Head Circumference
Measured: At birth
Neonatal Height
Height in cm (crown-heel length)
Measured: At birth
Neonatal Abdominal Circumference
Measured: At birth
Neonatal Ponderal Index
Ponderal index is calculated as 100 x weight(grams)/(crown-heel length).
Measured: At birth
Birth Weight >4000g
Measured: At birth
Birth Weight >90th Percentile
Measured: At birth
Birth Weight <2500g
Measured: At birth
Birth Weight <10th Percentile
Measured: At birth
Neonatal Morbidity - Need for NICU Care
Measured: From birth until 6 weeks of life.
Neonatal Morbidity - Preterm Birth
Delivery at gestational age <37 weeks.
Measured: At birth
Neonatal Morbidity - Respiratory Distress Syndrome Requiring Respiratory Support
Measured: From birth until 6 weeks of life.
Neonatal Morbidity - Jaundice Requiring Phototherapy
Measured: From birth until 6 weeks of life.
Neonatal Morbidity - Major Congenital Anomalies
Measured: From birth until 6 weeks of life.
Neonatal Morbidity - Apgar Score <7 at 5 Minutes
The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2.
(for example see: https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2015/10/the-apgar-score#:~:text=The%20Apgar%20score%20comprises%20five,0%2C%201%2C%20or%202)
Measured: At 5 minutes after birth
Neonatal Morbidity - Neonatal Hypoglycemia
serum glucose <2.6mmol/l on at least one occasion <60 minutes after delivery
Measured: First hour of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start6 Jun 2017
- Primary completion12 Jan 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland, HRB Clinical Research Facility Galway, University College Hospital Galway, Portiuncula University Hospital, University Hospital of Limerick, University Maternity Hospital Limerick, Clinical Research Support Unit, University of Limerick
- Responsible party
- Principal investigator, Fidelma Dunne, National University of Ireland, Galway, Ireland
- Investigators
- Prof. Fidelma Dunne, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980276
- Sponsor's protocol ID
- NUIG-2016-01
- Acronym
- EMERGE
- Status last verified
- Mar 2025
- First submitted
- 9 Nov 2016
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aguilar Macias DA, Alvarez-Iglesias A, Ferguson JM, Egan AM, O'Shea PM, Devane D, Newman C, McEvoy RP, FitzGerald M, O'Donnell MJ, Dunne FF. Early Metformin Initiation and Glycemic Outcomes in Gestational Diabetes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 Nov 2;9(11):e2635700. doi: 10.1001/jamanetworkopen.2026.35700.
PubMed 42975901Dunne F, Newman C, Alvarez-Iglesias A, O'Shea P, Devane D, Gillespie P, Egan A, O'Donnell M, Smyth A. Metformin and small for gestational age babies: findings of a randomised placebo-controlled clinical trial of metformin in gestational diabetes (EMERGE). Diabetologia. 2024 Dec;67(12):2660-2666. doi: 10.1007/s00125-024-06252-y. Epub 2024 Aug 31.
PubMed 39215812Dunne F, Newman C, Alvarez-Iglesias A, Ferguson J, Smyth A, Browne M, O'Shea P, Devane D, Gillespie P, Bogdanet D, Kgosidialwa O, Egan A, Finn Y, Gaffney G, Khattak A, O'Keeffe D, Liew A, O'Donnell M. Early Metformin in Gestational Diabetes: A Randomized Clinical Trial. JAMA. 2023 Oct 24;330(16):1547-1556. doi: 10.1001/jama.2023.19869.
PubMed 37786390Dunne F, Newman C, Devane D, Smyth A, Alvarez-Iglesias A, Gillespie P, Browne M, O'Donnell M. A randomised placebo-controlled trial of the effectiveness of early metformin in addition to usual care in the reduction of gestational diabetes mellitus effects (EMERGE): study protocol. Trials. 2022 Sep 21;23(1):795. doi: 10.1186/s13063-022-06694-y.
PubMed 36131291
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Placebo Controlled Trial of the Effectiveness of Early MEtformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects (EMERGE)
- ClinicalTrials.gov ID
- NCT02980276
- Acronym / sponsor ID
- EMERGE / NUIG-2016-01
- Conditions
- Gestational Diabetes
- Keywords
- Gestational Diabetes, Diabetes, Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland, HRB Clinical Research Facility Galway, University College Hospital Galway, Portiuncula University Hospital, University Hospital of Limerick, University Maternity Hospital Limerick, Clinical Research Support Unit, University of Limerick
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Posted 17 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the EMERGE trial is to determine whether metformin + usual care, compared to placebo + usual care (introduced at the time of initial diagnosis of GDM), reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive maternal weight gain; c) maternal and neonatal morbidities and, d) cost of treatment for women with Gestational Diabetes Mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Metformin HydrochlorideParticipants randomised to the treatment arm will receive active metformin in addition to standard care. Metformin tablets will be titrated according to a dosing schedule to achieve the pre-specified glucose targets. Tablets will be in 500mg doses and will commence at 1 tablet per day (500mg) increasing to a maximum of 5 tablets per day (2500mg). |
| Control | Placebo comparator | Other: PlaceboParticipants randomised to the placebo arm will receive placebo in addition to standard care. Placebo will be titrated according to the dosing schedule to achieve the pre-specified glucose targets. Placebo tablets will commence at 1 tablet per day and will be increased to a maximum of 5 tablets per day over 10 days as with the treatment group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willing and able to provide written informed consent
- Participants aged 18-50
- Pregnancy gestation up to 28 weeks (+ 6 days) confirmed by positive pregnancy test
- Singleton pregnancy as determined by scan
- Positive diagnosis of Gestational Diabetes Mellitus on a Oral Glucose Tolerance Test (OGTT) according to the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria if any one of the following are achieved: i) Fasting glucose >/= 5.1mmol/l and <7mmol/l, or ii) 1 hour post glucose load of >/=10mmol/l, or iii) 2 hour post glucose load of >/=8.5 mmol/l and <11.1mmo/l
Key exclusion criteria (13 listed)
- Participants who have an established diagnosis of diabetes (Type 1, Type 2, Monogenic or secondary)
- Participants with a fasting glucose > 7mmol/l or a 2h value > 11.1 mmol/l
- Multiple pregnancies (twins, triplets etc.) as determined by scan
- Known intolerance to metformin
- Known contraindication to the use of metformin which include: i) renal insufficiency (defined as serum creatinine of greater than 130 µmol/L or creatinine clearance <60 ml/min), ii) moderate to severe liver dysfunction (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, iii) shock or sepsis, and iv) previous hypersensitivity to metformin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin HydrochlorideWomen randomised to the metformin group will receive metformin 500mg once daily, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of 2500mg Metformin daily (5 tablets) or maximum tolerated dose, in addition to usual care (exercise and MNT), and taken until delivery. | Drug | Treatment |
| PlaceboWomen randomised to the placebo group will receive 1 placebo tablet once daily, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of five placebo tablets daily, in addition to usual care (exercise and MNT), and taken until delivery. | Other | Control |
Primary outcome
Primary Composite Outcome
Time frame: Enrolment through delivery, an average of 16 weeks.
The primary efficacy outcome was achieved if any participant experienced: * Insulin initiation * Fasting glucose value >5.1 mmol/l at 32weeks or 38 weeks gestation.
Insulation of Insulin
Time frame: Enrolment through delivery, an average of 16 weeks.
Initiation of insulin treatment at any time up to delivery.
32 secondary outcomes
Time to Insulin Initiation
Time frame: Time to Insulin Initiation, from date of randomization until the date of delivery, an average of 16 weeks..
Insulin Initiated
Time frame: Enrolment through delivery, an average of 16 weeks.
Fasting Hyperglycemia
Time frame: Measured at 32 and 38 weeks' gestation.
Insulin Dose Required
Time frame: Enrolment through delivery, an average of 16 weeks.
Gestational Weight Gain
Time frame: Enrolment through delivery, an average of 16 weeks.
Postpartum Impaired Fasting Glucose
Time frame: 12 weeks post-partum
Postpartum Impaired Glucose Tolerance
Time frame: 12 weeks postpartum
Postpartum Metabolic Syndrome
Time frame: 12 weeks postpartum
Gestational Age at Delivery
Time frame: At delivery, an average of 16 weeks after enrolment
Mode of Delivery - Cesarian Delivery
Time frame: At delivery, an average of 16 weeks after enrolment
Mode of Delivery - Emergency Cesarian Section
Time frame: At delivery, an average of 16 weeks after randomization.
Mode of Delivery - Induced
Time frame: At time of labor, an average of 16 weeks after enrolment.
Maternal Morbidity - Pregnancy-induced Hypertension
Time frame: From enrolment through 6 weeks postpartum, an average of 22 weeks.
Maternal Morbidity - Pre-eclampsia
Time frame: Enrolment through 6 weeks postpartum, an average of 22 weeks.
Maternal Morbidity - Antepartum Hemorrhage
Time frame: From enrolment through delivery, an average of 16 weeks.
Maternal Morbidity - Postpartum Hemorrhage
Time frame: From delivery through 6 weeks postpartum.
Birthweight
Time frame: At birth
Neonatal Head Circumference
Time frame: At birth
Neonatal Height
Time frame: At birth
Neonatal Abdominal Circumference
Time frame: At birth
Neonatal Ponderal Index
Time frame: At birth
Birth Weight >4000g
Time frame: At birth
Birth Weight >90th Percentile
Time frame: At birth
Birth Weight <2500g
Time frame: At birth
Birth Weight <10th Percentile
Time frame: At birth
Neonatal Morbidity - Need for NICU Care
Time frame: From birth until 6 weeks of life.
Neonatal Morbidity - Preterm Birth
Time frame: At birth
Neonatal Morbidity - Respiratory Distress Syndrome Requiring Respiratory Support
Time frame: From birth until 6 weeks of life.
Neonatal Morbidity - Jaundice Requiring Phototherapy
Time frame: From birth until 6 weeks of life.
Neonatal Morbidity - Major Congenital Anomalies
Time frame: From birth until 6 weeks of life.
Neonatal Morbidity - Apgar Score <7 at 5 Minutes
Time frame: At 5 minutes after birth
Neonatal Morbidity - Neonatal Hypoglycemia
Time frame: First hour of life.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42975901Aguilar Macias DA, Alvarez-Iglesias A, Ferguson JM, Egan AM, O'Shea PM, Devane D, Newman C, McEvoy RP, FitzGerald M, O'Donnell MJ, Dunne FF. Early Metformin Initiation and Glycemic Outcomes in Gestational Diabetes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 Nov 2;9(11):e2635700. doi: 10.1001/jamanetworkopen.2026.35700.
- Derived from this study: PubMed 39215812Dunne F, Newman C, Alvarez-Iglesias A, O'Shea P, Devane D, Gillespie P, Egan A, O'Donnell M, Smyth A. Metformin and small for gestational age babies: findings of a randomised placebo-controlled clinical trial of metformin in gestational diabetes (EMERGE). Diabetologia. 2024 Dec;67(12):2660-2666. doi: 10.1007/s00125-024-06252-y. Epub 2024 Aug 31.
- Derived from this study: PubMed 37786390Dunne F, Newman C, Alvarez-Iglesias A, Ferguson J, Smyth A, Browne M, O'Shea P, Devane D, Gillespie P, Bogdanet D, Kgosidialwa O, Egan A, Finn Y, Gaffney G, Khattak A, O'Keeffe D, Liew A, O'Donnell M. Early Metformin in Gestational Diabetes: A Randomized Clinical Trial. JAMA. 2023 Oct 24;330(16):1547-1556. doi: 10.1001/jama.2023.19869.
- Derived from this study: PubMed 36131291Dunne F, Newman C, Devane D, Smyth A, Alvarez-Iglesias A, Gillespie P, Browne M, O'Donnell M. A randomised placebo-controlled trial of the effectiveness of early metformin in addition to usual care in the reduction of gestational diabetes mellitus effects (EMERGE): study protocol. Trials. 2022 Sep 21;23(1):795. doi: 10.1186/s13063-022-06694-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Fidelma Dunne principal investigator
National University of Ireland, Galway, Ireland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin Hydrochloride in people with Gestational Diabetes, run by National University of Ireland, Galway, Ireland at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Composite Outcome (time frame: Enrolment through delivery, an average of 16 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980276, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.