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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01131676

Run by

Boehringer Ingelheim

People needed

7064

Starts

2010-07-01

Expected to finish

2015-04-01

Last updated by the study team

2016-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 <=10% for patients on background therapy or HbA1c >= 7.0% and <= 9.0% for drug naive patients
• Age >= 18 years
• Body Mass index <= 45 at Visit 1
• Signed and dated informed consent
• High cardiovascular risk

You may not qualify if…

• Uncontrolled hyperglycaemia with a glucose level >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

Where it is running

• 1245.25.10121 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 1245.25.10037 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
• 1245.25.10124 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 1245.25.10015 Boehringer Ingelheim Investigational Site — Little Rock, Alaska, United States
• 1245.25.10056 Boehringer Ingelheim Investigational Site — Gilbert, Arizona, United States
• 1245.25.10175 Boehringer Ingelheim Investigational Site — Peoria, Arizona, United States
• 1245.25.10072 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 1245.25.10048 Boehringer Ingelheim Investigational Site — Harrisburg, Arkansas, United States
• 1245.25.10035 Boehringer Ingelheim Investigational Site — Anaheim, California, United States
• 1245.25.10103 Boehringer Ingelheim Investigational Site — Encino, California, United States
• 1245.25.10158 Boehringer Ingelheim Investigational Site — Fresno, California, United States
• 1245.25.10126 Boehringer Ingelheim Investigational Site — Harbor City, California, United States
• 1245.25.10058 Boehringer Ingelheim Investigational Site — Huntington Park, California, United States
• 1245.25.10001 Boehringer Ingelheim Investigational Site — Lancaster, California, United States
• 1245.25.10102 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1245.25.10047 Boehringer Ingelheim Investigational Site — Los Gatos, California, United States
• 1245.25.10118 Boehringer Ingelheim Investigational Site — Palm Springs, California, United States
• 1245.25.10061 Boehringer Ingelheim Investigational Site — Riverside, California, United States
• 1245.25.10040 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1245.25.10055 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1245.25.10193 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1245.25.10027 Boehringer Ingelheim Investigational Site — Santa Rosa, California, United States
• 1245.25.10074 Boehringer Ingelheim Investigational Site — Stockton, California, United States
• 1245.25.10083 Boehringer Ingelheim Investigational Site — Valencia, California, United States
• 1245.25.10043 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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