Status:
COMPLETED
A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
Lead Sponsor:
Pfizer
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00886821
Start Date
October 1 2008
End Date
June 1 2011
Last Update
April 18 2017
Active Locations (2)
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1
Cetero Research
Miami Gardens, Florida, United States, 33169
2
Cetero Research - San Antonio
San Antonio, Texas, United States, 78229