Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females

A Phase 1, Double-blind, Placebo-controlled, Randomized, Parallel Group Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-04856883 In Adult Female Subjects With Type 2 Diabetes Mellitus

The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.

Inclusion Criteria:

• History of Type 2 diabetes and currently being treated with high dose metformin
• BMI between 22.0 and 40.0 kg/m2
• HbA1c between 7.0-10.0%
• Fasting C-peptide >1.21 ng/mL

Exclusion Criteria:

• History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications
• Treatment with anti-diabetic therapies other than metformin
• History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
• Males or women of childbearing potential