Clinical trial NCT00506298 (phase 2, status: completed)
Conditions: type 2 diabetes
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: bezafibrate + diflunisal, bezafibrate + placebo
SMILES: OC(=O)C1=C(O)C=CC(=C1)C1=C(F)C=C(F)C=C1, CC(C)(OC1=CC=C(CCNC(=O)C2=CC=C(Cl)C=C2)C=C1)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Must voluntarily give written informed consent

          -  Must be between 18-75 years of age

          -  Must have Type 2 diabetes for ≥ 6 months

          -  HgbA1C between 7.0% and 9.5%

          -  FPG > 6.7 mmol/L (120 mg/dL)

          -  BMI: Lower limit of 27 kg/m2 and an upper Limit of 45 kg/m2

          -  Treatment with a stable dosage for ≥ 8 weeks of either Glucophage metformin) ≥ 1000
             and ≤ 2500 mg/day OR Glucophage XR ≤ 2000 mg/day

          -  eGFR ≥ 70 mL/min

        Exclusion Criteria:

          -  History of any clinically significant atherosclerotic disorder including myocardial
             infarction (within 6 months of screening), angina, stroke, peripheral vascular disease
             or congestive heart failure

          -  Known hypersensitivity or idiosyncratic reaction related to fibrates or NSAIDs
             including photo-allergic or phototoxic reactions to fibrates

          -  Subjects in whom acute asthmatic attacks, urticaria, or rhinitis are precipitated by
             aspirin or other NSAIDs

          -  History of clinically significant (as determined by the investigator cardiac,
             hematologic, hepatobiliary, peptic ulcer, renal, immunologic, metabolic, urologic,
             pulmonary, endocrinologic, neurologic, dermatologic, psychiatric, and/or other major
             disease

          -  Type 1 Diabetes

          -  Evidence of Cushing's syndrome, untreated hypothyroidism or other disorders that may
             lead to secondary weight gain, insulin resistance, or Type 2 diabetes

          -  Proliferative diabetic retinopathy or significant neuropathic symptoms that also limit
             activities of daily living

          -  History of malignancy (except for treated or excised basal cell carcinoma)

          -  Surgery within the 90 days prior to screening except for minor dental or cosmetic
             procedures

          -  History of drug or alcohol abuse (as defined by the Investigator)

          -  History of opportunistic infection

          -  Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g.,
             septicemia) within 3 months prior to screening

          -  Fever or symptomatic viral or bacterial infection within 2 weeks prior to screening

          -  Positive for HCV antibody

          -  Positive for HBsAg

          -  Known positive for HIV antibody

          -  Pharmacologic treatment with statins, unless dosage has been stable ≥ three months and
             is unlikely to change over the course of the study.

          -  Treatment with any concomitant medication that has not been at a stable dose for at
             least 28 days prior to screening.

          -  Currently taking or planning to take during the trial:

        Sulphonylureas, Injected hypoglycemic (exanatide or insulin), Weight loss medications,
        Thiazolidenediones, Glucocorticoids (inhaled glucocorticoids are permitted), Digoxin,
        Anticoagulants, Phenytoin, Loratadine, Erythromycin, MAO-inhibitors, NSAIDs (ASA ≤ 81 mg/d
        is permitted), COX-2 Inhibitors, Cholestryramine or fibrates, DPP-IV inhibitors, Any herbal
        medications unless reviewed with study doctor

          -  Alanine aminotransferase ALT) or aspartate aminotransferase (AST laboratory values
             that exceed > 2.0 x upper limit of normal (ULN)

          -  White blood cell (WBC) count < 4.0 x 109 /L or >14.0 X 109 /L

          -  Hemoglobin < 105 g/L in females and < 110 g/L in males (< 10.5 g/dL in females and <
             11.0 g/dL in males)

          -  Participation in another clinical trial and/or treatment received with any
             investigational agent within 30 days before the initial dose of study medication

          -  Female subject who is pregnant or lactating or of child bearing potential and not
             using acceptable methods of contraception (birth control pills, barriers or
             abstinence)

          -  Unwilling or unable to comply with the requirements of this protocol, including the
             presence of any condition (physical, mental, or social) that is likely to affect the
             subject's return for follow-up visits on schedule

          -  Other unspecified reasons that, in the opinion of the Investigator or sponsor make the
             subject unsuitable for enrollment