BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo BI 10773 high dose
Drug: BI 10773 high dose
Drug: BI 10773 low dose
Drug: Placebo BI 10773 low dose

Registration Number: NCT01131676

Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 7064

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo BI 10773 high dose	Placebo tablets matching BI 10773
Placebo	Placebo BI 10773 low dose	Placebo tablets matching BI 10773
BI 10773 low dose	Placebo BI 10773 high dose	BI 10773 tablets once daily
BI 10773 high dose	BI 10773 high dose	BI 10773 tablets once daily
BI 10773 low dose	BI 10773 low dose	BI 10773 tablets once daily
BI 10773 high dose	Placebo BI 10773 low dose	BI 10773 tablets once daily

Primary Outcome Measures

Name	Time	Method
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.	From randomisation to individual end of observation, up to 4.6 years	Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke. Percentage of patients with the event are presented.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)	From randomisation to individual end of observation, up to 4.6 years	Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented.
Percentage of Participants With New Onset Albuminuria	From randomisation to individual end of observation, up to 4.6 years	New onset albuminuria defined as urine albumin / creatinine ratio (UACR) ≥30 mg/g. Percentage of patients with the event are presented.
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	From randomisation to individual end of observation, up to 4.6 years	The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial. Percentage of patients with the event are presented.
Percentage of Participants With Silent MI	From randomisation to individual end of observation, up to 4.6 years	Silent MI; defined as presence in the ECG of: * Any Q-wave in leads V2-V3 ≥0.02 seconds or QS complex in leads V2 and V3 * Q-wave ≥0.03 seconds and ≥0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF) * R-wave ≥0.04 seconds in V1-V2 and R/S ≥1 with a concordant positive T-wave in the absence of a conduction defect. It was also required that there had been no adjudicated and confirmed event of either acute MI, hospitalisation for unstable angina, coronary revascularisation procedures or stent thrombosis following randomisation up to and including the date of the specified ECG measurement. Percentage of patients with the event are presented.
Percentage of Participants With New Onset Macroalbuminuria	From randomisation to individual end of observation, up to 4.6 years	New onset macroalbuminuria defined as UACR \>300 mg/g. Percentage of patients with the event are presented.
Percentage of Participants With the Composite Microvascular Outcome	From randomisation to individual end of observation, up to 4.6 years	Composite microvascular outcome defined as: * Initiation of retinal photocoagulation * Vitreous haemorrhage * Diabetes-related blindness, or * New or worsening nephropathy defined as: * New onset of macroalbuminuria; or * Doubling of serum creatinine level accompanied by an eGFR (based on modification of diet in renal disease (MDRD) formula) ≤45 mL/min/1.73m2; or * Initiation of continuous renal replacement therapy, or * Death due to renal disease. Percentage of patients with the event are presented.

Trial Locations

Locations (615): 1245.25.10043 Boehringer Ingelheim Investigational Site
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Birmingham, Alabama, United States
1245.25.10121 Boehringer Ingelheim Investigational Site
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Birmingham, Alabama, United States
1245.25.10037 Boehringer Ingelheim Investigational Site
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Huntsville, Alabama, United States
1245.25.10124 Boehringer Ingelheim Investigational Site
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Mobile, Alabama, United States
1245.25.10015 Boehringer Ingelheim Investigational Site
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Little Rock, Alaska, United States
1245.25.10056 Boehringer Ingelheim Investigational Site
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Gilbert, Arizona, United States
1245.25.10175 Boehringer Ingelheim Investigational Site
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Peoria, Arizona, United States
1245.25.10072 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, United States
1245.25.10048 Boehringer Ingelheim Investigational Site
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Harrisburg, Arkansas, United States
1245.25.10035 Boehringer Ingelheim Investigational Site
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Anaheim, California, United States
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1245.25.10043 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States