Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo identical to BI10773 high dose; BI 10773; BI 10773 open label; Placebo identical to BI10773 low dose; Placebo identical to BI10773 low dose; Placebo identical to BI10773 high dose; Placebo identical to Sitagliptin 100mg; Placebo identical to Sitagliptin 100mg; BI10773; Sitagliptin; Placebo identical to Sitagliptin 100mg; Placebo identical to BI10773 low dose; Placebo identical to BI10773 high dose
Intervention description: placebo tablets once daily; BI 10773 low dose tablet once daily; Patients receive BI 10773 high dose tablets open label once daily; placebo tablets once daily; placebo tablets once daily; placebo tablets once daily; placebo tablets once daily; placebo tablets once daily; BI 10773 high dose tablets once daily; Sitagliptin tablets 100 mg once daily; placebo tablets once daily; placebo tablets once daily; placebo tablets once daily
Intervention MeSH terms: Sitagliptin Phosphate; Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 986.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773
      compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM
      with insufficient glycaemic control. For the open-label part of the study the objective is to
      estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM
      with very poor glycaemic control.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of type 2 diabetes mellitus prior to informed consent;

          2. Male and female patients on diet and exercise regimen who are drug-naïve;

          3. HbA1c >= 7.0% and <= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c >
             10.0% at visit 1 (screening) for the open-label BI 10773 arm;

          4. Age >= 20 (Japan); Age >= 18 (countries other than Japan);

          5. BMI <= 45 kg/m2 at Visit 1 (screening);

          6. Signed and dated written informed consent by date of Visit 1

        Exclusion criteria:

          1. Uncontrolled hyperglycaemia;

          2. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA
             within 3 months prior to informed consent;

          3. Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN;

          4. Impaired renal function (eGFR<50 ml/min);

          5. Bariatric surgery within the past two years or other GI surgeries;

          6. Medical history of cancer;

          7. Contraindications to sitagliptin;

          8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell;

          9. Treatment with any anti-diabetes drug within 12 weeks prior to randomisation;

         10. Treatment with anti-obesity drugs or any other treatment leading to unstable body
             weight;

         11. Current treatment with systemic steroids or change in dosage of thyroid hormones
             within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder
             except T2DM;

         12. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and
             not practicing an acceptable method of birth control;

         13. Alcohol or drug abuse;

         14. Intake of an investigational drug in another trial within 30 days prior to intake of
             study medication in this trial;

         15. Any other clinical condition that would jeopardize patients safety while participating
             in this clinical trial