Clinical trial NCT00653185 (phase 2, status: completed)
Conditions: diabetes mellitus
ICD codes: P70.2, O24.92, Z83.3, E10.65, E10.9, E11.65, E11.9
Drugs: syr-472, syr-472, syr-472, syr-472, 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:

          -  Has a historical diagnosis of type 2 diabetes mellitus.

          -  Has undergone less than 7 days of any antidiabetic therapy except lifestyle
             modification (diet/exercise) within 8 weeks prior to Screening; or has received
             metformin monotherapy for at least 8 weeks prior to Screening and maintained a stable
             daily dose of metformin for at least 12 weeks prior to randomization.

          -  The subject receiving metformin monotherapy at randomization must have been at least
             75% compliant with his or her regimen during the Run-in/Stabilization Period as
             determined by subject diary and investigator assessment.

          -  Has received no treatment with antidiabetic agents other than metformin within the 8
             weeks prior to Screening.

          -  Has a glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive, at
             Screening and at the Week -1 Visit.

          -  The subject's fasting C-peptide concentration is greater than or equal to 0.8 ng/mL.

          -  Has a fasting plasma glucose concentration less than 275 mg/dL.

          -  If regularly uses other non-excluded medications, must be on a stable dose for at
             least the 4 weeks prior to Screening.

          -  Has a systolic blood pressure reading less than 160 mm Hg and a diastolic pressure
             reading less than 100 mm Hg.

          -  Has a hemoglobin value greater than or equal to 12 g/dL for men and greater than or
             equal to 10 g/dL for women.

          -  Has an alanine aminotransferase level is less than or equal to 3 times the upper limit
             of normal.

          -  Males have a serum creatinine value less than 1.5 mg/dL; females have a serum
             creatinine value less than 1.4 mg/dL.

          -  Has a urine albumin/creatinine ratio less than 1000 μg/mg.

          -  Has a thyroid-stimulating hormone level less than or equal to the upper limit of the
             normal range and is clinically euthyroid.

          -  Females must be not be pregnant or lactating, and must agree to use adequate
             contraception throughout the duration of the study.

          -  Is able and willing to monitor his or her own blood glucose concentrations with a home
             glucose monitor.

          -  Has no major illness or debility that in the investigator's opinion prohibits the
             subject from completing the study.

        Exclusion Criteria

          -  Is being concurrently treated with antidiabetic therapy other than metformin and
             lifestyle intervention.

          -  Has a history of cancer, other than squamous cell or basal cell carcinoma of the skin
             that has not been in full remission for at least 5 years prior to Screening.

          -  Has a history of laser treatment for proliferative diabetic retinopathy within the 6
             months prior to Screening.

          -  Has a history of treated diabetic gastric paresis.

          -  Has New York Heart Association class III or IV heart failure regardless of therapy.

          -  Has a history of coronary angioplasty, underwent coronary stent placement or coronary
             bypass surgery, or suffered a myocardial infarction, or stroke within the 6 months
             prior to Screening.

          -  Has a history of any hemoglobinopathy that may affect determination of glycosylated
             hemoglobin.

          -  Has a history of infection with human immunodeficiency virus.

          -  Has a history of a psychiatric disorder that in the investigator's opinion will affect
             the subject's ability to participate in the study.

          -  Has ingested or received systemically injected glucocorticoids within the 3 months
             prior to randomization. Inhaled corticosteroids are allowed.

          -  Has used prescription or over-the-counter weight-loss drugs within the 3 months prior
             to randomization.

          -  Has received any investigational drug within the 30 days prior to Screening or has
             received an investigational antidiabetic drug within the 3 months prior to Screening.

          -  Has received previous treatment in an investigational study of SYR-472.

          -  Has a known hypersensitivity to any compound related to SYR-472.