Clinical trial NCT01924767 (phase 1, status: completed)
Conditions: diabetes mellitus, type 2
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: bi 10773 placebo, bi 10773, bi 10773 placebo, bi 10773, bi 10773 placebo, bi 10773 placebo, bi 10773, bi 10773
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@]1(CCOC1)OC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@]2([H])O[C@]([H])(CO)[C@@]([H])(O)[C@]([H])(O)[C@@]2([H])O)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@]1(CCOC1)OC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@]2([H])O[C@]([H])(CO)[C@@]([H])(O)[C@]([H])(O)[C@@]2([H])O)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@]1(CCOC1)OC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@]2([H])O[C@]([H])(CO)[C@@]([H])(O)[C@]([H])(O)[C@@]2([H])O)C=C1, [H][C@@]1(CCOC1)OC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@]2([H])O[C@]([H])(CO)[C@@]([H])(O)[C@]([H])(O)[C@@]2([H])O)C=C1
Eligibility criteria:

        Inclusion criteria:

          1. Male and postmenopausal or hysterectomised 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 thiazolidindiones with at least one agent taken at 50%
             of its maximum dose or less.

          2. Glycosylated haemoglobin A1 (HbA1c) £ 8.5 % at screening.

          3. Age >21 and Age <70 years (male and hysterectomised female patients) Age >60 and Age
             <70 years (postmenopausal female patients)

          4. Body Mass Index (BMI) >18.5 and <40 kg/m2

          5. Signed and dated written informed consent prior to admission to the study in
             accordance with GCP and the local legislation

        Exclusion criteria:

          1. Antidiabetic treatment with insulin or glitazones or with more than one oral
             hypoglycaemic agent (except if 2 agents and at least one of them not taken at more
             than 50% of its maximum dose)

          2. Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) on two consecutive days during
             washout.

          3. Glycosylated haemoglobin A1 (HbA1c) >8.5% at screening

          4. Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia
             and medically treated hypertension, such as:

               -  Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy,
                  vegetative disorders, diabetic foot)

               -  Renal insufficiency (calculated creatinine clearance < 80 ml/min/1.73m²)

               -  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 (Transistoric
                  ischaemic attack)

               -  Neurological disorders (such as epilepsy) or psychiatric disorders

               -  Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections)

               -  Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder

          5. History of relevant allergy/hypersensitivity (including allergy to drug or its
             excipients)

          6. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
             QTc interval >450 ms)

          7. A history of additional risk factors for TdP (torsade des pointes) (e.g., heart
             failure, hypokalemia, family history of sudden death before the age of 50)