BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BI 10773 low dose; Placebo BI 10773 high dose; BI 10773 high dose; Placebo BI 10773 low dose; Placebo BI 10773 low dose; Placebo BI 10773 high dose
Intervention description: BI 10773 tablets once daily; Placebo tablets identical to BI 10773; BI 10773 tablets once daily; Placebo tablets identical to BI 10773; Placebo tablets identical to BI 10773; Placebo tablets identical to BI 10773
Intervention MeSH terms: Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 7064.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of type 2 diabetes mellitus prior to informed consent

          2. 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.

          3. Glycosylated haemoglobin (HbA1c) of >= 7.0% and <=10% for patients on background
             therapy or HbA1c >= 7.0% and <= 9.0% for drug naive patients

          4. Age >= 18 years

          5. Body Mass index <= 45 at Visit 1

          6. Signed and dated informed consent

          7. High cardiovascular risk

        Exclusion criteria:

          1. 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)

          2. 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.

          3. Planned cardiac surgery or angioplasty within 3 months

          4. 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.

          5. Bariatric surgery within the past two years and other gastrointestinal surgeries that
             induce chronic malabsorption

          6. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g.
             malaria, babesiosis, haemolytic anemia)

          7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for
             cancer within the last 5 years

          8. Contraindications to background therapy according to the local label

          9. 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

         10. 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

         11. 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

         12. 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

         13. Participation in another trial with an investigational drug within 30 days prior to
             informed consent

         14. Any other clinical condition that would jeopardize patients safety while participating
             in this clinical trial

         15. Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent