Targeting Inflammation Using Salsalate for Type 2 Diabetes-Stage II

Exclusion Criteria

• •1. No prior participation in Stage I of TINSAL-T2D ; exception: a participant who failed screening for HbA1c in Stage I will be allowed to re-screen for Stage II.
• •2. Type 1 diabetes and/or history of ketoacidosis determined by medical history
• •3. History of severe diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation
• •4. History of long-term therapy with insulin (\>30 days) within the last year
• •5. Therapy with rosiglitazone (Avandia) or pioglitazone (Actos), alone or in combination in the previous 6 months; or exendin-4 (Byetta), alone or in combination in the previous 3 months
• •6. Pregnancy or lactation
• •7. Patients requiring oral corticosteroids within 3 months or recurrent continuous oral corticosteroid treatment (more than 2 weeks)
• •8. Use of weight loss drugs \[e.g., Xenical (orlistat), Meridia (sibutramine), Acutrim (phenylpropanol-amine), or similar over-the-counter medications\] within 3 months of screening or intentional weight loss of ≥ 10 lbs in the previous 6 months
• •9. Surgery within 30 days prior to screening
• •10. Serum creatinine \>1.4 for women and \>1.5 for men or eGFR \<60 \[possible chronic kidney disease stage 3 or greater calculated using the Modification of Diet in Renal Disease (MDRD) equation
• •11. History of chronic liver disease including hepatitis B or C
• •12. History of peptic ulcer or endoscopy demonstrated gastritis
• •13. History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV)
• •14. History of malignancy, except participants who have been disease-free for greater than 10 years, or whose only malignancy has been basal or squamous cell skin carcinoma
• •15. New York Heart Association Class III or IV cardiac status or hospitalization for congestive heart failure
• •16. History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months
• •17. Uncontrolled hypertension (defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>95 mmHg on three or more assessments on more than one day). If on blood pressure medications, dosing should be stable for 2 weeks prior to randomization.
• •18. History of drug or alcohol abuse, or current weekly alcohol consumption \>10 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed DCCktail containing 1 ounce of alcohol)
• •19. Hemoglobin \<12 g/dL (males), \<10 g/dL (females) at screening\*
• •20. Platelets \<100,000 cu mm at screening
• •21. AST (SGOT) \>2.50 x ULN or ALT (SGPT) \>2.50 x ULN at screening
• •22. Total Bilirubin \>1.50 x ULN at screening
• •23. Triglycerides (TG) \>500 mg/dL at screening
• •24. Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study
• •25. Previous allergy to aspirin
• •26. Chronic or continuous use (daily for more than 7 days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months
• •27. Use of warfarin (Coumadin), clopidogrel (Plavix), dipyridamole (Persantine), heparin or other anticoagulants
• •28. Use of probenecid (Benemid, probalan), sulfinpyrazone (Anturane) or other uricosuric agents
• •29. Macroalbuminuria, defined as spot urine protein \>300 mcg/mg Cr at screening
• •30. Pre-existing chronic tinnitus