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Comparison · NCT03968224-sae

Metformin/Dapagliflozin vs Metformin: serious adverse events

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. Metformin/Dapagliflozin vs Metformin: serious adverse events. Trial comparisons, record NCT03968224-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03968224-sae

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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 1000.0664wilson
Risk in group 2000.0653wilson
Risk difference, group 1 minus group 20-0.06530.0664newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Metformin/Dapagliflozin
Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.~Dapagliflozin/Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided in combination with Dapagliflozin 10 mg per day. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
054EG000
Group 2Metformin
Metformin 1,700 mg/day~Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
055EG001

Harm

What it counts
Total, serious adverse events
Time frame
12 months.

Source ClinicalTrials.gov

Trial

Title
Effectiveness of Dapagliflozin for Weight Loss
NCT number
NCT03968224
Phases
PHASE2, PHASE3
Conditions
PreDiabetes, Obesity, Morbid, Diabetes Mellitus, Type 2
Interventions
Dapagliflozin/Metformin, Metformin
Lead sponsor
Centro Medico Nacional Siglo XXI IMSS
Results first posted
2025-10-15

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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