Clinical trial NCT01422876 (phase 3, status: completed)
Conditions: diabetes mellitus, type 2
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: high dose fdc, bi 10773 high dose, high dose fdc placebo, low dose fdc placebo, high dose fdc placebo, high dose fdc placebo, low dose fdc placebo, low dose fdc placebo, high dose bi 10773 placebo, low dose fdc, high dose fdc placebo, bi 10773 low dose, high dose bi 10773 placebo, high dose bi 10773 placebo, linagliptin, low dose fdc placebo, linagliptin placebo, bi 10773 low dose placebo, linagliptin placebo, low dose bi 10773 placebo, linagliptin placebo, high dose bi 10773 placebo, bi 10773 low dose placebo, low dose bi 10773 placebo, linagliptin placebo
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Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of type 2 diabetes mellitus prior to informed consent

          2. Male and female patients on diet and exercise regimen who are drug-naïve (defined as
             absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin
             for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on
             the maximum tolerated dose or the maximum dose according to local label) unchanged for
             12 weeks prior to randomisation.

          3. Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3
             mmol/mol) at Visit 1 (screening)

        Exclusion criteria:

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

          2. Any other antidiabetic drug within 12 weeks prior to randomization (except metformin
             background therapy as defined via inclusion criterion 2)

          3. Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation
             myocardial infarction and unstable angina pectoris), stroke or (transient ischemic
             attack) TIA within 3 months prior to informed consent