4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo (middle dose); Placebo; BI 10773; BI 10773; BI 10773; Placebo (high dose); BI 10773; Placebo (low dose)
Intervention description: Placebo tablets once a day; Placebo tablets once a day; BI 10773 middle dose tablets once a day; BI 10773 high dose tablets once a day; BI 10773 middle dose tablets once a day; Placebo tablets once a day; BI 10773 low dose tablets 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: 100.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety,
      and tolerability of once daily oral administration of BI 10773 administered for 28 days in
      Japanese patients with T2DM.
    

Eligibility criteria:

        Inclusion criteria:

          1. Japanese male or female patients with T2DM treated with diet and exercise alone or
             with one hypoglycaemic drug other than glitazones.

          2. Hemoglobin A1c (HbA1c) at screening (Visit 1)

               -  For patients treated with 1 other oral antidiabetic drug: HbA1c between 6.5% and
                  9.0%.

               -  For patients not treated with any antidiabetic drug: HbA1c between 7.0% and
                  10.0%.

          3. Age between 20 and 70 years

          4. Body mass index (BMI) between18.0 and 40.0 kg/m2

          5. Signed and dated written informed consent before admission to the trial in accordance
             with the Good Clinical Practice (GCP) and the local legislation.

        Exclusion criteria:

          1. Antidiabetic treatment with insulin or glitazones within 3 months before obtaining
             informed consent or with more than 1 oral hypoglycaemic agent at the time of informed
             consent

          2. Fasted blood glucose of >240 mg/dL (>13.3 mmol/L) or a randomly determined blood
             glucose level of >400 mg/dL (22.2 mmol/L) on 2 consecutive days during wash-out
             period.

          3. Myocardial infarction, stroke, or transient ischaemic attack within 6 months before
             informed consent.

          4. Clinically relevant concomitant diseases other than T2DM, hyperlipidaemia, and
             medically treated hypertension before the first administration such as

               -  Renal insufficiency (calculated estimated glomerular filtration rate <60)

               -  Cardiac insufficiency of New York Heart Association (NYHA) II-IV or other known
                  cardiovascular diseases including hypertension of >160/95 mmHg,

               -  Neurological disorders (such as epilepsy) or psychiatric disorders

               -  Acute or clinically relevant chronic infections (e.g., human immunodeficiency
                  virus, hepatitis, repeated urogenital infections)

               -  Any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder

          5. Patients under treatment with any concomitant medication except for the following
             drugs at the time of informed consent.:

               -  Statins.

               -  Antihypertensives (diuretics not allowed)

               -  alpha-Blockers for benign prostate hypertrophy

               -  Occasional use of acetylsalicylic acid, ibuprofen, or paracetamol

          6. Additional inclusion/exclusion criteria apply