Phase 3
Completed N=7,028
BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).
Source: ClinicalTrials.gov NCT01131676 ↗Enrolled (actual)
7,028
Serious AEs
39.6%
Results posted
May 2016
Primary outcomePrimary: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. — 12.1; 10.4; 10.5; 10.5 percentage of participants — p=<0.0001
◆ Published Evidence
Established
27citations · ~14 / year
Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
Summary
The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.
Linked Publications (5)
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Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
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Effect of empagliflozin on total myocardial infarction events by type and additional coronary outcomes: insights from the randomized EMPA-REG OUTCOME trial.
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Baseline Cardiovascular Risk Factor Control in Patients With Type 2 Diabetes and Coronary Disease Versus Stroke: Secondary Analysis of Cardiovascular Outcome Trials.
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Empagliflozin and Rapid Kidney Function Decline Incidence in Type 2 Diabetes: An Exploratory Analysis From the EMPA-REG OUTCOME Trial.
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Effect of Qualifying Atherosclerotic Cardiovascular Disease Diagnosis Proximity on Cardiovascular Risk and Benefit of Empagliflozin in the EMPA-REG OUTCOME Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. |
12.1; 10.4; 10.5; 10.5 | <0.0001 sig |
| SECONDARY Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris |
14.3; 12.8; 12.8; 12.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With Silent MI |
1.2; 1.6; 1.6; 1.6 | 0.4172 |
| SECONDARY Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated) |
4.1; 2.6; 2.8; 2.7 | 0.0017 sig |
| SECONDARY Percentage of Participants With New Onset Albuminuria |
51.2; 51.5; 51.5; 51.5 | 0.2547 |
| SECONDARY Percentage of Participants With New Onset Macroalbuminuria |
16.2; 10.9; 11.5; 11.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With the Composite Microvascular Outcome |
20.5; 13.9; 14.1; 14.0 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Diagnosis of type 2 diabetes mellitus prior to informed consent
- Male or female patients on diet and exercise regimen who are drug naive or pre treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization.
- Glycosylated haemoglobin (HbA1c) of >= 7.0% and = 7.0% and = 18 years
- Body Mass index 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
- Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase ALT or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening and/or run in.
- Planned cardiac surgery or angioplasty within 3 months
- Impaired renal function, defined as Glomerular Filtration Rate <30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) during screening or run in.
- Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
- Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
- Contraindications to background therapy according to the local label
- Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
- Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus
- Pre-menopausal women (last menstruation <+ 1 year prior to informed consent) who:
- are nursing or pregnant or
- are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner
- Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
- Participation in another trial with an investigational drug within 30 days prior to informed consent
- Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
- Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent
Data sourced from ClinicalTrials.gov (NCT01131676) 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.