4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion criteria:
- Japanese male or female patients with T2DM treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.
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%.
- Age between 20 and 70 years
- Body mass index (BMI) between18.0 and 40.0 kg/m2
- 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:
- 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
- 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.
- Myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.
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
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
- Additional inclusion/exclusion criteria apply
Sites / Locations
- 1245.15.003 Boehringer Ingelheim Investigational Site
- 1245.15.002 Boehringer Ingelheim Investigational Site
- 1245.15.001 Boehringer Ingelheim Investigational Site
- 1245.15.005 Boehringer Ingelheim Investigational Site
- 1245.15.004 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
BI 10773 low dose quaque die (QD)
BI 10773 mid-low dose QD
BI 10773 mid-high dose QD
BI 10773 high dose QD
Placebo
patient to receive a BI 10773 low dose tablet and a placebo tablet once daily
patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily
patient to receive two tablets of BI 10773 middle dose once daily
patient to receive a BI 10773 high dose tablet and a placebo tablet once daily
patient to receive two tablets of placebo once daily