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Comparison · NCT02500979-sae

Placebo & Regular Insulin vs Pramlintide & Regular Insulin: 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. Placebo & Regular Insulin vs Pramlintide & Regular Insulin: serious adverse events. Trial comparisons, record NCT02500979-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02500979-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 100.00000000000000001390.121wilson
Risk in group 2000.107wilson
Risk difference, group 1 minus group 20-0.1070.121newcombe 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 1Placebo & Regular InsulinPlacebo was similar sterile solution without pramlintide028EG000
Group 2Pramlintide & Regular InsulinPramlintide was administered by sc infusion at a concentration of 1000ug/ml032EG001

Harm

What it counts
Total, serious adverse events
Time frame
Over two 24-hour treatment periods with a 2-week washout period between periods.

Source ClinicalTrials.gov

Trial

Title
Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus
NCT number
NCT02500979
Phases
PHASE1
Conditions
Type 1 Diabetes Mellitus
Interventions
Pramlintide acetate, Placebo, Lispro insulin U-100, Regular insulin U-100
Lead sponsor
AstraZeneca
Results first posted
2018-11-02

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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