Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Empagliflozin in Chinese Female and Male Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BI10773; Placebo; Placebo; Placebo; BI10773
Intervention description: patient to receive a tablet containing high dose BI10773 p.o. plus one placebo; patient to receive two placebos; patient to receive two placebos; patient to receive two placebos; patient to receive a tablet containing low dose BI10773 p.o. plus one placebo
Intervention MeSH terms: Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      the pharmacokinetics, pharmacodynamics and safety and tolerability of single and multiple
      oral doses of BI 10773 at low dose once daily (q.d.) and high dose q.d. administered to
      Chinese female and male patients with type 2 diabetes will be investigated.
    

Eligibility criteria:

        Inclusion criteria:

          1. Chinese male and female patients with proven diagnosis of type 2 diabetes mellitus
             treated with diet and exercise only or on a maximum of two oral antidiabetic agents
             except thiazolidinediones with at least one agent taken at 50% of its maximum dose or
             less, unchanged for at least 12 weeks before randomization

          2. Glycosylated haemoglobin A1(HbA1c)<=8.5% and >=7.0% at screening,age>=21 and age<=70
             years (male and female patients),BMI>=19 and <=40 kg/m2

          3. Signed and dated written informed consent by date of Visit 1 in accordance with GCP
             and local legislation.

        Exclusion criteria:

          1. Patient who did not discontinue the antidiabetic treatment with insulin or glitazones,
             DPP-IV at least before 12 weeks before randomization

          2. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an
             overnight fast at screening visit

          3. Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia
             and medically treated hypertension, such as:

        4 Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative
        disorders, diabetic foot) 5 Renal insufficiency (calculated creatinine clearance < 80
        ml/min/1.73m²) 6 Cardiac insufficiency NYHA II-IV, myocardial infarction, other known
        cardiovascular diseases including hypertension > 160/95mmHg (measured at training visit and
        each of the timepoints of Day -1), stroke and TIA 7 Neurological disorders (such as
        epilepsy) or psychiatric disorders 8 Acute or relevant chronic infections (e.g. HIV,
        repeated urogenital infections) 9 Any gastrointestinal, hepatic, respiratory, endocrine or
        immunological disorder 10. History of relevant allergy/hypersensitivity (including allergy
        to drug or its excipients) 11. A marked baseline prolongation of QT/QTc interval (e.g., ECG
        demonstration of a QTc interval >450 ms ) at screening visit