4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)

A Phase II, Randomised, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 (1 mg, 5 mg, 10 mg, and 25 mg) for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus

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.

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