A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients

Inclusion Criteria:

- Male or female 18 years or older

- Patient diagnosed with Type 2 diabetes mellitus and chronic kidney disease

- On a stable regimen of ACE inhibitors and/or ARB drugs for a minimum of 4 weeks

- Not expected to start dialysis for one year

- Patient has blood pressure less than or equal to 145/90 mm Hg

- Patient has UACR greater than or equal to 200 mg/g if male and 300 mg/g if female but
not more than 5000 mg/g

- Patient has glycosylated hemoglobin A1c less than or equal to 10.5%

Exclusion Criteria:

- Patient has concurrent condition such as uncontrolled inflammatory disease, acute
infection or other unstable illnesses

- Patient has a history of allergy or sensitivity to pentoxifylline or methylxanthines

- Patient has acute, active and/or unstable renal impairment or has been hospitalized
for acute renal failure within the previous year

- Patient has active malignancy or history of neoplastic disease

- Patient has a QTc interval greater than 450 milliseconds

- Patient has ALT or AST greater than 3 times the upper limit of normal or a potassium
greater than or equal to 5.5mEq/L at screening

- Patient is breast feeding or pregnant