A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy

A 2-week, Phase 1b, Randomized, Double-Blind, Placebo- Controlled, Multi-Dose, Dose-Escalating Study With PF-03882845 And One Dose Of Spironolactone To Evaluate Safety, Tolerability, Pharmacokinetics And Pharmacodynamics In Subjects With Type 2 Diabetes Mellitus And Albuminuria

PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-03882845 in this population.

This study was terminated on 12-Sep-2012; this decision was made due to poor recruitment and overall business strategy. The study was not terminated for safety reasons nor for lack of efficacy.

Inclusion Criteria:

• Males and/or Females between 18-65 years, inclusive.
• Body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or greater than 110 lb.
• Have type 2 diabetes mellitus.
• On stable dose of anti-diabetic and anti-hypertensive medication prior to screening.

Exclusion Criteria:

• Recent evidence or medical history of unstable concurrent disease.
• Cardiovascular event within 3 months prior to screening.
• History of renal transplant.
• History of hospitalization for acute kidney injury or acute kidney dialysis within 6 months prior to screening.