Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo (low dose); Placebo (low dose); Placebo (mid dose); Placebo (high dose); BI 10773; Placebo (mid dose); Placebo (high dose); Placebo (high dose); BI 10773; BI 10773; Placebo (mid dose); Placebo (high dose); Placebo (low dose); Placebo (low dose); BI 10773; Placebo (mid dose)
Intervention description: Placebo tablets once a day; Placebo tablets once a day; Placebo tablets once a day; Placebo tablets once a day; BI 10773 tablets low dose once a day; Placebo tablets once a day; Placebo tablets once a day; Placebo tablets once a day; BI 10773 tablets mid-high dose once a day; BI 10773 tablets high dose once a day; Placebo tablets once a day; Placebo tablets once a day; Placebo tablets once a day; Placebo tablets once a day; BI 10773 tablets mid-low dose once a day; Placebo tablets once a day
Intervention MeSH terms: Empagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 547.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in
      Japanese patients with T2DM at first treatment period. The second treatment period is
      required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese
      patients with T2DM according to the ICH E1 guideline.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of type 2 diabetes mellitus prior to informed consent

          -  Male and female patients on diet and exercise regimen who are:

               1. drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed
                  consent.

               2. pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has
                  to be unchanged for 10 weeks prior to informed consent.

          -  HbA1c at Visit 1a:

               1. for patients who are drug naïve: HbA1c >=7.0 to =<10.0%

               2. for patients treated with one oral antidiabetic drug: HbA1c >=6.5 to =<9.0%

          -  HbA1c of >=7.0% and =<10% at Visit 2 (start of run-in)

        Exclusion criteria:

          -  Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after an
             overnight fast during wash-out/placebo run-in period and confirmed by a second
             measurement (not on the same day).

          -  Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior
             to informed consent

          -  Impaired renal function, defined as calculated eGFR <60 ml/min (MDRD formula) during
             screening and/or wash-out period and/or run-in phase.

          -  Bariatric surgery within the past 2 years and other gastrointestinal surgeries that
             induce chronic malabsorption

          -  Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g.
             malaria, babesiosis, haemolytic anemia)

          -  Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks 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