Phase 3
N=535
RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects
Gestational Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02980276 ↗Enrolled (actual)
535
Serious AEs
36.2%
Results posted
Mar 2025
Primary outcome: Primary: Primary Composite Outcome — 150; 167 Participants — p=0.13
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metformin Hydrochloride (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National University of Ireland, Galway, Ireland
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Composite Outcome |
150; 167 | 0.13 |
| PRIMARY Insulation of Insulin |
101; 134 | 0.004 sig |
| SECONDARY Time to Insulin Initiation |
68; 58.7 | 0.001 sig |
| SECONDARY Insulin Initiated |
94; 106 | 0.005 sig |
| SECONDARY Fasting Hyperglycemia |
94; 106 | 0.178 |
| SECONDARY Insulin Dose Required |
20.4; 2.2 | 0.17 |
| SECONDARY Gestational Weight Gain |
0.88; 1.96 | 0.003 sig |
| SECONDARY Postpartum Impaired Fasting Glucose |
51; 52 | 0.99 |
| SECONDARY Postpartum Impaired Glucose Tolerance |
15; 16 | 0.911 |
| SECONDARY Postpartum Metabolic Syndrome |
20; 25 | 0.519 |
| SECONDARY Gestational Age at Delivery |
39.1; 39.1 | 0.66 |
| SECONDARY Mode of Delivery - Cesarian Delivery |
114; 100 | 0.367 |
| SECONDARY Mode of Delivery - Emergency Cesarian Section |
53; 53 | 1.0 |
| SECONDARY Mode of Delivery - Induced |
73; 87 | 0.603 |
| SECONDARY Maternal Morbidity - Pregnancy-induced Hypertension |
31; 28 | 0.739 |
| SECONDARY Maternal Morbidity - Pre-eclampsia |
10; 5 | 0.282 |
| SECONDARY Maternal Morbidity - Antepartum Hemorrhage |
15; 27 | 0.058 |
| SECONDARY Maternal Morbidity - Postpartum Hemorrhage |
51; 63 | 0.24 |
| SECONDARY Birthweight |
3393; 3505 | 0.005 sig |
| SECONDARY Neonatal Head Circumference |
34.7; 34.7 | 0.82 |
| SECONDARY Neonatal Height |
51; 51.7 | 0.02 sig |
| SECONDARY Neonatal Abdominal Circumference |
33.4; 33.3 | 0.72 |
| SECONDARY Neonatal Ponderal Index |
2.6; 2.6 | 0.68 |
| SECONDARY Birth Weight >4000g |
20; 39 | 0.02 sig |
| SECONDARY Birth Weight >90th Percentile |
17; 39 | 0.003 sig |
| SECONDARY Birth Weight <2500g |
16; 9 | .012 sig |
| SECONDARY Birth Weight <10th Percentile |
15; 7 | 0.13 |
| SECONDARY Neonatal Morbidity - Need for NICU Care |
41; 33 | 0.38 |
| SECONDARY Neonatal Morbidity - Preterm Birth |
24; 17 | 0.33 |
| SECONDARY Neonatal Morbidity - Respiratory Distress Syndrome Requiring Respiratory Support |
24; 18 | 0.42 |
| SECONDARY Neonatal Morbidity - Jaundice Requiring Phototherapy |
1; 0 | >0.99 |
| SECONDARY Neonatal Morbidity - Major Congenital Anomalies |
10; 7 | 0.62 |
| SECONDARY Neonatal Morbidity - Apgar Score <7 at 5 Minutes |
1; 1 | >0.99 |
| SECONDARY Neonatal Morbidity - Neonatal Hypoglycemia |
36; 34 | 0.9 |
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 morbidities and, d) cost of treatment for women with Gestational Diabetes Mellitus.
Eligibility Criteria
Inclusion Criteria
- 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 /=10mmol/l, or iii) 2 hour post glucose load of >/=8.5 mmol/l and 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
- 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
Data sourced from ClinicalTrials.gov (NCT02980276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.