Multiple Dose Escalation Trial Of PF-04603629 Given To Subjects With Type 2 Diabetes Mellitus

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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) mimetic currently marketed as Byetta®) fused to human transferrin (a naturally occuring protein) in order to increase the concentration of exendin-4 in the blood. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04603629 following multiple escalating subcutaneous doses in adult subjects with T2DM.

Key facts

Study ID

NCT00637338

Run by

Pfizer

People needed

42

Starts

2008-04-01

Expected to finish

2008-09-01

Last updated by the study team

2009-07-31

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Wichita, Kansas, United States
• Pfizer Investigational Site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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