Comparison · NCT02980276-977fc4f4
Treatment vs Control: Primary Composite Outcome
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Treatment vs Control: Primary Composite Outcome. Trial comparisons, record NCT02980276-977fc4f4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02980276-977fc4f4
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.568 | 0.508 | 0.627 | wilson | |
| Risk in group 2 | 0.637 | 0.578 | 0.693 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0692 | -0.151 | 0.0143 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.891 | 0.776 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.749 | 0.527 | 1.06 | log | |
| Number needed to treat, for one fewer participant with the outcome on Treatment than on Control | 14.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Treatment | 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).~Metformin Hydrochloride: 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. | 150 | 264 | OG000 |
| Group 2 | Control | 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.~Placebo: 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. | 167 | 262 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Primary Composite Outcome
- Description
- 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.
- Time frame
- Enrolment through delivery, an average of 16 weeks.
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects
- NCT number
- NCT02980276
- Phases
- PHASE3
- Conditions
- Gestational Diabetes
- Interventions
- Metformin Hydrochloride, Placebo
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Results first posted
- 2025-03-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02980276?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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