{
  "release_id": "5dcd9b263fe17744",
  "id": "cardio:empa-reg-outcome",
  "owner": "cardio",
  "kind": "study",
  "slug": "empa-reg-outcome",
  "name": "EMPA-REG OUTCOME: empagliflozin and cardiovascular outcomes in type 2 diabetes",
  "aliases": [
    "EMPA-REG OUTCOME"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A large trial of people with type 2 diabetes at high risk of heart and blood-vessel disease. They took empagliflozin 10 mg or 25 mg a day, or placebo, on top of usual care. Empagliflozin lowered the chance of a combined heart event, and fewer people died from heart causes or from any cause. Heart attacks and strokes alone did not differ significantly. Genital infections were more common on empagliflozin.",
  "summary_technical": "Randomized, double-blind trial sponsored by Boehringer Ingelheim with Eli Lilly as registry collaborator (NCT01131676). 7020 patients were treated, median observation 3.1 years. Primary outcome (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke), pooled empagliflozin against placebo: 490 of 4687 (10.5%) against 282 of 2333 (12.1%), hazard ratio 0.86 (95.02% CI 0.74 to 0.99; P=0.04 for superiority). The registry counts 7064 enrolled.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": null,
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT01131676",
      "normalized_value": "NCT01131676",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "metabolism",
        "heart"
      ],
      "condition-area": [
        "diabetes-and-metabolic-disease"
      ]
    }
  },
  "payload": {
    "design": "Multicenter, international, randomized, parallel-group, double-blind trial (registry official title). The registry records phase 3 and double masking. The registry names the study drug by a code (BI 10773).",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct01131676-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2010-07",
      "type": null,
      "snapshot": "cardio:ctgov-nct01131676-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2015-04",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01131676-2026-10-14"
    },
    "completion_date": {
      "date": "2015-04",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01131676-2026-10-14"
    },
    "results_first_posted": null,
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct01131676-2026-10-14"
      },
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        "code": "AR",
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    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 7064,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct01131676-2026-10-14"
      },
      {
        "count": 7020,
        "basis": "treated",
        "unit": "patients",
        "snapshot": "cardio:pubmed-26378978-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:empa-reg-arm-low-dose",
        "label": "BI 10773 low dose",
        "intervention": null,
        "description": "Empagliflozin once daily at the lower dose; the abstract names the doses as 10 mg and 25 mg. The registry labels the study drug BI 10773."
      },
      {
        "id": "cardio:empa-reg-arm-high-dose",
        "label": "BI 10773 high dose",
        "intervention": null,
        "description": "Empagliflozin once daily at the higher dose; the abstract names the doses as 10 mg and 25 mg. The registry labels the study drug BI 10773."
      },
      {
        "id": "cardio:empa-reg-arm-placebo",
        "label": "Placebo",
        "intervention": null,
        "description": "Placebo once daily."
      }
    ],
    "findings": []
  },
  "content_digest": "8ecbb697807595b67bf45d90ecd23aade9d9cd8e09261d742071de56a50e77ee",
  "review": {
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    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Lists type 2 diabetes as its condition",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:type-2-diabetes",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
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          "locator": "protocolSection.conditionsModule.conditions[0]"
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        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "sponsored_by",
        "label": "Lead sponsor on the registry record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:boehringer-ingelheim",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
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          "locator": "protocolSection.sponsorCollaboratorsModule.leadSponsor.name"
        },
        "primary": false,
        "role": "lead",
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      },
      {
        "predicate": "sponsored_by",
        "label": "Collaborator on the registry record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:eli-lilly",
        "other_entity_in_atlas": true,
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        "evidence": {
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        "role": "collaborator",
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      {
        "predicate": "investigates",
        "label": "Tests this medicine (the registry title names empagliflozin)",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:empagliflozin",
        "other_entity_in_atlas": true,
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    ],
    "incoming": []
  },
  "page_path": "studies/empa-reg-outcome/",
  "context_path": "api/v1/context/cardio--empa-reg-outcome.md"
}