Phase 3
Completed N=17,160
Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events
Diabetes Mellitus, Non-Insulin-Dependent · High Risk for Cardiovascular Event
Source: ClinicalTrials.gov NCT01730534 ↗
Enrolled (actual)
17,160
Serious AEs
38.6%
Results posted
Dec 2019
Primary outcomePrimary: Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke — 756; 803 Participants — p=0.172
◆ Published Evidence
Established
65citations · ~16 / year
Dapagliflozin and Prevention of Kidney Disease Among Patients With Type 2 Diabetes: Post Hoc Analyses From the DECLARE-TIMI 58 Trial.
Summary
This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.
Linked Publications (5)
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Dapagliflozin and Prevention of Kidney Disease Among Patients With Type 2 Diabetes: Post Hoc Analyses From the DECLARE-TIMI 58 Trial.
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Association of Cardiac Biomarkers With Major Adverse Cardiovascular Events in High-risk Patients With Diabetes: A Secondary Analysis of the DECLARE-TIMI 58 Trial.
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Effects of dapagliflozin on hospitalisations in people with type 2 diabetes: post-hoc analyses of the DECLARE-TIMI 58 trial.
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Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
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Galectin-3 and kidney function in type 2 diabetes treated with dapagliflozin: Analysis from DECLARE-TIMI 58.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke |
756; 803 | 0.172 |
| PRIMARY Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. |
417; 496 | 0.005 sig |
| SECONDARY Subjects Included in the Renal Composite Endpoint: Confirmed Sustained ≥40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death. |
370; 480 | <0.001 sig |
| SECONDARY Subjects Included in the Endpoint of All-cause Mortality. |
529; 570 | 0.198 |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures
- Female or male aged ≥40 years
- Diagnosed with Type 2 Diabetes
- High Risk for Cardiovascular events
Exclusion Criteria
- Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- Chronic cystitis and/or recurrent urinary tract infections
- Pregnant or breast-feeding patients
Data sourced from ClinicalTrials.gov (NCT01730534) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.