{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:declare-timi-58",
  "owner": "cardio",
  "kind": "study",
  "slug": "declare-timi-58",
  "name": "DECLARE-TIMI 58: dapagliflozin and cardiovascular outcomes in type 2 diabetes",
  "aliases": [
    "DECLARE-TIMI 58",
    "DECLARE-TIMI58"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A large trial of people with type 2 diabetes who had heart or blood-vessel disease or were at risk of it. They took dapagliflozin 10 mg a day or placebo. Dapagliflozin did not lower the rate of the main combined outcome of heart attack, stroke and heart-related death. It did lower the combined outcome of heart-related death or hospital stays for heart failure, because of fewer heart-failure stays. Ketoacidosis and genital infections were more common on dapagliflozin.",
  "summary_technical": "Randomized, double-blind, placebo-controlled trial sponsored by AstraZeneca (NCT01730534). 17,160 patients were evaluated (10,186 without atherosclerotic cardiovascular disease), median follow-up 4.2 years; the registry counts 17190 enrolled. Noninferiority for major adverse cardiovascular events was met (upper boundary of the 95% CI below 1.3). Major adverse cardiovascular events: 8.8% against 9.4%, hazard ratio 0.93 (95% CI 0.84 to 1.03; P=0.17). Cardiovascular death or hospitalization for heart failure: 4.9% against 5.8%, hazard ratio 0.83 (0.73 to 0.95).",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": null,
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT01730534",
      "normalized_value": "NCT01730534",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "metabolism",
        "heart"
      ],
      "condition-area": [
        "diabetes-and-metabolic-disease"
      ]
    }
  },
  "payload": {
    "design": "Multicenter, randomized, double-blind, placebo-controlled trial with parallel groups. The registry records phase 3 and quadruple masking.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2013-04-25",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2018-09-11",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
    },
    "completion_date": {
      "date": "2018-09-11",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
    },
    "results_first_posted": {
      "date": "2019-12-26",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "AR",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "AU",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "BE",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "BR",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "BG",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "CN",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "CZ",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "FR",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "DE",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "HU",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "IN",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "IL",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "IT",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "JP",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "MX",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "NL",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "PH",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "PL",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "RO",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "RU",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "SK",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "ZA",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "KR",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "ES",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "SE",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "TW",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "TH",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "UA",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "GB",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "VN",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "TR",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      },
      {
        "code": "HK",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 17190,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct01730534-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:declare-timi-58-arm-dapagliflozin",
        "label": "Dapagliflozin",
        "intervention": null,
        "description": "Dapagliflozin 10 mg once daily."
      },
      {
        "id": "cardio:declare-timi-58-arm-placebo",
        "label": "Placebo",
        "intervention": null,
        "description": "Placebo tablet."
      }
    ],
    "findings": []
  },
  "content_digest": "713a02a44c248cec5cc8a3bc5ff5a6c443dd79352475170ccd680cb1db78dfff",
  "review": {
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    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Enrolled people with type 2 diabetes",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:type-2-diabetes",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:pubmed-30415602-2026-10-14",
          "locator": "Abstract, METHODS, sentence 1"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
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      {
        "predicate": "sponsored_by",
        "label": "Lead sponsor on the registry record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:astrazeneca",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
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          "locator": "protocolSection.sponsorCollaboratorsModule.leadSponsor.name"
        },
        "primary": false,
        "role": "lead",
        "valid_from": null,
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      {
        "predicate": "investigates",
        "label": "Tests this medicine",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:dapagliflozin",
        "other_entity_in_atlas": true,
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        "evidence": {
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          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
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    ],
    "incoming": []
  },
  "page_path": "studies/declare-timi-58/",
  "context_path": "api/v1/context/cardio--declare-timi-58.md"
}