Status:
TERMINATED
Multiple Dose Escalation Trial Of PF-04603629 Given To Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Pfizer
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
PF-04603629 is being investigated for the treatment of Type 2 diabetes mellitus (T2DM). Specifically, PF-04603629 is a protein that is a combination of exendin-4 (a glucagon-like peptide-1 (GLP-1) mim...
Detailed Description
B0571002 was terminated August 19 2008 due to the decision to discontinue development of PF-04603629 after observing (in both B0571001 and B0571002) a trend for a reversible increase in heart rate wit...
Eligibility Criteria
Inclusion
- Patients with type 2 diabetes mellitus who are not taking any treatment or are taking metformin (with no change in the treatment, including dose, over the past 2 months). Subjects previously treated with a sulfonylurea in combination with metformin may be eligible if switched over to metformin only for a minimum of 4 weeks before dosing.
- Male and/or female subjects (females will be women of non-childbearing potential) between the ages of 18 and 70 years, inclusive.
- Body Mass Index (BMI) of approximately 22 to 40 kg/m2
- Fasting C-peptide test result must be \>0.4 nmol/L.
- HbA1c ≥7% and ≤11%. If the subject requires to be washed off a sulfonylurea, the HbA1c limits will be ≥7% and ≤9.5%.
Exclusion
- Screening fasting blood glucose, ≤60 or ≥270 mg/dL. One repeat screening fasting blood glucose will be allowed.
- Previous treatment with an approved or investigational GLP-1 mimetic.
- Have a known allergy to yeast, yeast-derived or yeast containing products.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00637338
Start Date
April 1 2008
End Date
September 1 2008
Last Update
July 31 2009
Active Locations (4)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
2
Pfizer Investigational Site
Miami, Florida, United States, 33169
3
Pfizer Investigational Site
Wichita, Kansas, United States, 67214
4
Pfizer Investigational Site
Portland, Oregon, United States, 97239