Clinical trial NCT01193218 (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: placebo (low dose), placebo (low dose), placebo (mid dose), placebo (high dose), bi 10773, placebo (mid dose), placebo (high dose), placebo (high dose), bi 10773, bi 10773, placebo (mid dose), placebo (high dose), placebo (low dose), placebo (low dose), bi 10773, placebo (mid dose)
SMILES: 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, 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, 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, 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, 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, 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, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of type 2 diabetes mellitus prior to informed consent

          -  Male and female patients on diet and exercise regimen who are:

               1. drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed
                  consent.

               2. pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has
                  to be unchanged for 10 weeks prior to informed consent.

          -  HbA1c at Visit 1a:

               1. for patients who are drug naïve: HbA1c >=7.0 to =<10.0%

               2. for patients treated with one oral antidiabetic drug: HbA1c >=6.5 to =<9.0%

          -  HbA1c of >=7.0% and =<10% at Visit 2 (start of run-in)

        Exclusion criteria:

          -  Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after an
             overnight fast during wash-out/placebo run-in period and confirmed by a second
             measurement (not on the same day).

          -  Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior
             to informed consent

          -  Impaired renal function, defined as calculated eGFR <60 ml/min (MDRD formula) during
             screening and/or wash-out period and/or run-in phase.

          -  Bariatric surgery within the past 2 years and other gastrointestinal surgeries that
             induce chronic malabsorption

          -  Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g.
             malaria, babesiosis, haemolytic anemia)

          -  Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to
             informed consent or any other treatment at the time of screening (i.e. surgery,
             aggressive diet regimen, etc.) leading to unstable body weight