A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics

A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Escalating Subcutaneous Doses Of Cvx-096 In Type 2 Diabetic Adult Subjects

The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.

Inclusion Criteria:

• Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum.
• Hb A1c between 7-10%.
• Fasting C-peptide >0.4 nmol/L.

Exclusion Criteria:

• History of clinically significant chronic conditions other than T2DM not well controlled by either diet or medications.
• Patients with pancreatitis or considered a high risk for pancreatitis.
• History of contraindications to metformin therapy.
• Previous treatment with an approved or investigational GLP 1 mimetic.