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

NCT00637338 · Terminated

Last updated 2026-05-28

This clinical trial tested different increasing doses of the drug PF-04603629, given as injections under the skin, to see how the drug moves through the body in adults with type 2 diabetes.

Status Terminated Stopped early and will not restart.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, triple-blind treatment study

Participants 42 people

Who can join Ages 18–70 · all sexes

Timeline Started 2008-04 · est. completion 2008-09

Where 4 sites · United States

What this study is testing ClinicalTrials.gov NCT00637338 ↗

Description as written by the study sponsor.

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.

Treatments tested

PF-04603629 Biologic

Subjects will be given either PF-04603629 or Placebo in a blinded fashion. Subjects will receive 4 weekly injections of PF-04603629 or Placebo.
Placebo Biologic

Subjects will be given either PF-04603629 or Placebo in a blinded fashion during the study. Subjects will receive 4 weekly injections of PF-04603629 or Placebo.

Main thing measured	To characterize the pharmacokinetics of PF-04603629 in serum after administration of escalating, multiple, subcutaneously injected doses of PF-04603629 to subjects with T2DM.
Sponsor	Pfizer
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00637338 ↗