BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus

A Randomised, Double-blind, Placebo-controlled, Multiple Dose Phase II Study of BI 1356 BS (0.5 mg, 2.5 mg, and 10 mg in Tablet q.d. Administered Orally for 28 Days) to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Japanese Patients With Type 2 Diabetes Mellitus

Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356 BS (0.5 mg, 2.5 mg, and 10 mg) administered orally once daily for 28 days in Japanese patients with type 2 diabetes mellitus.

Inclusion Criteria:

• Japanese patients with a diagnosis of type 2 diabetes mellitus treated with diet and/or exercise only or with one or two oral hypoglycaemic agents except glitazones

• Glycosylated haemoglobin A1 (HbA1c)

  • <= 8.5% at screening for patients treated with diet and/or exercise and/or one oral hypoglycaemic agent or
  • <= 8.0% at screening for patients treated with two oral hypoglycaemic agents

• Age ≥21 and ≤ 70 years

• BMI ≥ 17.6 and ≤ 35 kg/m2

Exclusion Criteria:

• Any finding of the medical examination including blood pressure, pulse rate and electrocardiogram (ECG) deviating from normal and of not acceptable clinical relevance
• Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency (NYHA II-IV), known cardiovascular diseases including hypertension (>150/95 mmHg), stroke, and transient ischemic attack (TIA).
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, except for type 2 diabetes mellitus, hyperlipidaemia and medically treated hypertension
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders except polyneuropathy
• Chronic or relevant acute infections (e.g., human immunodeficiency virus (HIV), hepatitis)
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug before drug administration except anti-hypertensives, acetylsalicylic acid, and statins
• Use of drugs decreasing blood glucose within 10 days before drug administration
• Participation in another trial with an investigational drug within two months before drug administration
• Alcohol abuse
• Drug abuse
• Blood donation (100 mL or more within four weeks before drug administration)
• Excessive physical activities (within one week before drug administration or during the trial)
• Any laboratory value outside the reference range and the clinical relevance is not acceptable (or the value is more than three times higher than the upper limit of the normal range, e.g., liver enzymes such as aspartate aminotransferase (AST(serum glutamate oxaloacetate transaminase/ SGOT)), alanine transaminase (ALT(serum glutamate pyruvate transaminase/ SGPT)), alkaline phosphatase (γALP), and lactate dehydrogenase (LDH)
• Fasted blood glucose >240 mg/dL (=13.3 mmol/L) on two consecutive days during washout
• Serum creatinine above 1.3 mg/dL at screening
• Pregnancy or child-bearing potential patients and breast-feeding patients
• Not willing to use adequate contraception (condom use plus another form of contraception, e.g., spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until one month after the last intake