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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Biological: Placebo; Biological: PF-04603629

Study type: Interventional

Funder types: Industry

Identifiers

NCT00637338

B0571002

Details and patient eligibility

About

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.

Full 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 within the normal range, which occurred at efficacious doses. Thus, the compound was primarily terminated due to safety concerns, although there was no immediate safety risk to any subject in the study.

Enrollment: 42 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

42 participants in 2 patient groups, including a placebo group

PF-04603629

Experimental group

Description:

The dose range initially planned is 3 mg up to 70 mg, although the specific doses administered may be modified based on emerging study data.

Treatment:

Biological: PF-04603629

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo