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Comparison · NCT02980276-2e4b7489

Treatment vs Control: Insulation of Insulin

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: Insulation of Insulin. Trial comparisons, record NCT02980276-2e4b7489. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02980276-2e4b7489

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3830.3260.442wilson
Risk in group 20.5110.4510.571wilson
Risk difference, group 1 minus group 2-0.129-0.211-0.0439newcombe hybrid score
Risk ratio, group 1 over group 20.7480.6160.908log
Odds ratio, group 1 over group 20.5920.4180.837log
Number needed to treat, for one fewer participant with the outcome on Treatment than on Control7.764.7322.8from the risk difference interval

Groups2

Group 2 names the comparator: control.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Treatment
Participants randomised to the treatment arm received 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).
101264OG000
Group 2Control
Participants randomised to the placebo arm received 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.
134262OG001

Outcome

Type
PRIMARY
Title
Insulation of Insulin
Description
Initiation of insulin treatment at any time up to delivery.
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

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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