Clinical trial NCT02183324 (phase 2, status: completed)
Conditions: diabetes mellitus, type 2
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: low dose of bi 1356 bs, medium dose of bi 1356 bs, high dose of bi 1356 bs, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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