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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Biological: CVX-096

Study type: Interventional

Funder types: Industry

Identifiers

NCT00886821

B1111001

CVX-096-101 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 114 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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114 participants in 1 patient group

1

Experimental group

Treatment:

Biological: CVX-096