Trial · NCT02980276

RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects

NCT02980276, Phase 3, Completed, National University of Ireland, Galway, Ireland; results first posted 2025-03-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects. Trials, record NCT02980276. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02980276

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects
NCT number: NCT02980276
Status: Completed
Phases: Phase 3
Enrollment: 535 participants, actual
Lead sponsor: National University of Ireland, Galway, Ireland
Conditions: Gestational Diabetes
Interventions: Metformin Hydrochloride, Placebo
First posted: 2016-12-02
Last updated: 2025-03-17
Results first posted: 2025-03-17

Source ClinicalTrials.gov

Registered outcomes34

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Primary Composite Outcome	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.
Primary	Insulation of Insulin	Enrolment through delivery, an average of 16 weeks.	Initiation of insulin treatment at any time up to delivery.
Secondary	Time to Insulin Initiation	Time to Insulin Initiation, from date of randomization until the date of delivery, an average of 16 weeks..	Time to Insulin Initiation, from date of randomization until the date of delivery.
Secondary	Insulin Initiated	Enrolment through delivery, an average of 16 weeks.	Whether or not insulin was initiated at any time during the study.
Secondary	Fasting Hyperglycemia	Measured at 32 and 38 weeks' gestation.	Number of women with fasting hyperglycemia at 32wks or at 38wks gestation.
Secondary	Insulin Dose Required	Enrolment through delivery, an average of 16 weeks.	Insulin dose required in any participant requiring insulin.
Secondary	Gestational Weight Gain	Enrolment through delivery, an average of 16 weeks.	Change in weight (kg) from randomization until last visit before delivery
Secondary	Postpartum Impaired Fasting Glucose	12 weeks post-partum	Impaired fasting glucose at 12 weeks postpartum
Secondary	Postpartum Impaired Glucose Tolerance	12 weeks postpartum
Secondary	Postpartum Metabolic Syndrome	12 weeks postpartum

1 to 10 of 34Source ClinicalTrials.gov

See all 34 registered outcomes

Outcomes34

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Primary Composite Outcome	Enrolment through delivery, an average of 16 weeks.	Population of pregnancies followed up until delivery. 268 were randomised to Treatment Group, of whom 264 received Metformin as randomised. Two participants delivered outside the country; delivery and neonatal information was available for the remaining 262 participants. Among those randomised to Treatment Group, 264 Pregnancies were included in the Primary Outcome Analysis. All 262 patients randomised to placebo were followed until delivery and included in Primary Outome Analysis.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Insulation of Insulin	Enrolment through delivery, an average of 16 weeks.	Population of pregnancies followed up until delivery. 268 were randomised to Treatment Group, of whom 264 received Metformin as randomised. Two participants delivered outside the country; delivery and neonatal information was available for the remaining 262 participants. Among those randomised to Treatment Group, 264 Pregnancies were included in the Primary Outcome Analysis. All 262 patients randomised to placebo were followed until delivery and included in Primary Outome Analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Insulin Initiation	Time to Insulin Initiation, from date of randomization until the date of delivery, an average of 16 weeks..	Pregnancies followed up until delivery.	days	MEAN
SECONDARY	Insulin Initiated	Enrolment through delivery, an average of 16 weeks.	Population of pregnancies followed up until delivery. 268 were randomised to Treatment Group, of whom 264 received Metformin as randomised. Two participants delivered outside the country; delivery and neonatal information was available for the remaining 262 participants. Among those randomised to Treatment Group, 264 Pregnancies were included in the Primary Outcome Analysis. Data for this outcome available for 263 in Treatment group.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Fasting Hyperglycemia	Measured at 32 and 38 weeks' gestation.	Participants having fasting glucose levels measured at 32 and/or 38 weeks' gestation. Data available for 255 in the Treatment group and 248 in the Control group.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Insulin Dose Required	Enrolment through delivery, an average of 16 weeks.	Population of pregnancies followed up until delivery. 268 were randomised to Treatment Group, of whom 264 received Metformin as randomised. Two participants delivered outside the country; delivery and neonatal information was available for the remaining 262 participants. Among those randomised to Treatment Group, 264 Pregnancies were included in the Primary Outcome Analysis which includes Insulin Initiation (yes/no).	IU	MEAN
SECONDARY	Gestational Weight Gain	Enrolment through delivery, an average of 16 weeks.	Population of pregnancies followed up until delivery. 268 were randomised to Treatment Group, of whom 264 received Metformin as randomised. Two participants delivered outside the country; delivery and neonatal information was available for the remaining 262 participants.	kg	MEAN
SECONDARY	Postpartum Impaired Fasting Glucose	12 weeks post-partum	Participants followed until 12 weeks postpartum who contributed samples for analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Postpartum Impaired Glucose Tolerance	12 weeks postpartum	Participants followed until 12 weeks postpartum who contributed samples.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Postpartum Metabolic Syndrome	12 weeks postpartum	Participants followed until 12 weeks postpartum who contributed samples	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 34Source ClinicalTrials.gov

See all 34 outcomes

Results by group68

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Primary Composite Outcome	Treatment	150		Participants
Primary Composite Outcome	Control	167		Participants
Insulation of Insulin	Treatment	101		Participants
Insulation of Insulin	Control	134		Participants
Time to Insulin Initiation	Treatment	68	Standard Deviation 38.1	days
Time to Insulin Initiation	Control	58.7	Standard Deviation 37	days
Insulin Initiated	Treatment	94		Participants
Insulin Initiated	Control	106		Participants
Fasting Hyperglycemia	Treatment	94		Participants
Fasting Hyperglycemia	Control	106		Participants

1 to 10 of 68Source ClinicalTrials.gov

See all 68 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment	268
Overall Study	STARTED	Control	267
Overall Study	Included in Analysis of Primary Outcome	Treatment	264
Overall Study	Included in Analysis of Primary Outcome	Control	262
Overall Study	COMPLETED	Treatment	235
Overall Study	COMPLETED	Control	240
Overall Study	NOT COMPLETED	Treatment	33
Overall Study	NOT COMPLETED	Control	27

Source ClinicalTrials.gov

Adverse events2,416

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Treatment - Mother	66	264	70
other	Anaemia	Blood and lymphatic system disorders	Control - Mother	77	262	79
other	Anaemia	Blood and lymphatic system disorders	Treatment - Fetus/Neonate	0	264	0
other	Anaemia	Blood and lymphatic system disorders	Control - Fetus/Neonate	0	262	0
other	Leukopenia	Blood and lymphatic system disorders	Treatment - Mother	0	264	0
other	Leukopenia	Blood and lymphatic system disorders	Control - Mother	0	262	0
other	Leukopenia	Blood and lymphatic system disorders	Treatment - Fetus/Neonate	1	264	1
other	Leukopenia	Blood and lymphatic system disorders	Control - Fetus/Neonate	0	262	0
other	Lymphadenopathy	Blood and lymphatic system disorders	Treatment - Mother	1	264	1
other	Lymphadenopathy	Blood and lymphatic system disorders	Control - Mother	0	262	0

1 to 10 of 2,416Source ClinicalTrials.gov

See all 2,416 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment - Mother	2	264
Total, all-cause mortality	Control - Mother	1	262
Total, all-cause mortality	Treatment - Fetus/Neonate	1	264
Total, all-cause mortality	Control - Fetus/Neonate	1	262
Total, other adverse events	Treatment - Mother	225	264
Total, other adverse events	Control - Mother	247	262
Total, other adverse events	Treatment - Fetus/Neonate	157	264
Total, other adverse events	Control - Fetus/Neonate	172	262
Total, serious adverse events	Treatment - Mother	79	264
Total, serious adverse events	Control - Mother	72	262

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36131291	DERIVED	PubMed
37786390	DERIVED	PubMed
39215812	DERIVED	PubMed
42975901	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons25

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Treatment vs Control: Neonatal Morbidity - Neonatal Hypoglycemia	Trial comparisons
Treatment vs Control: Postpartum Impaired Glucose Tolerance	Trial comparisons
Treatment vs Control: Insulation of Insulin	Trial comparisons
Treatment vs Control: Neonatal Morbidity - Apgar Score <7 at 5 Minutes	Trial comparisons
Treatment vs Control: Fasting Hyperglycemia	Trial comparisons
Treatment vs Control: Maternal Morbidity - Antepartum Hemorrhage	Trial comparisons
Treatment vs Control: Neonatal Morbidity - Preterm Birth	Trial comparisons
Treatment vs Control: Insulin Initiated	Trial comparisons
Treatment vs Control: Neonatal Morbidity - Major Congenital Anomalies	Trial comparisons
Treatment vs Control: Maternal Morbidity - Postpartum Hemorrhage	Trial comparisons

1 to 10 of 25

See all 25 trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02980276

GET https://conductscience.org/api/trials/v1/NCT02980276/registered?page=2

API reference For AI assistants