NCT00637338

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) 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

July 31, 2009

Status Verified

November 1, 2008

Enrollment Period

5 months

First QC Date

March 10, 2008

Last Update Submit

July 30, 2009

Conditions

Diabetes Mellitus, Type 2

Keywords

Long-acting GLP-1 Diabetes

Outcome Measures

Primary Outcomes (3)

  • To characterize the pharmacokinetics of PF-04603629 in serum after administration of escalating, multiple, subcutaneously injected doses of PF-04603629 to subjects with T2DM.

    4 weeks per dose group

  • To evaluate the effects of multiple, escalating, subcutaneously injected doses of PF-04603629, on the pharmacodynamic responses of glucose, insulin, C-peptide and glucagon during a mixed meal tolerance test (MMTT).

    4 weeks per dose group

  • To describe the safety and tolerability of escalating, multiple, subcutaneously injected doses of PF-04603629 administered to subjects with T2DM.

    4 weeks per dose group

Secondary Outcomes (1)

  • To evaluate the effect of multiple, escalating, subcutaneously injected doses of PF-04603926 on additional exploratory efficacy biomarkers related to this drug's target in subjects with T2DM.

    4 weeks per dose group

Study Arms (2)

PF-04603629

EXPERIMENTAL

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.

Biological: PF-04603629

Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

PF-04603629BIOLOGICAL

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

PF-04603629
PlaceboBIOLOGICAL

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.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pfizer Investigational Site

Phoenix, Arizona, 85013, United States

Location

Pfizer Investigational Site

Miami, Florida, 33169, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67214, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97239, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

PF 04603629

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 10, 2008

First Posted

March 17, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

July 31, 2009

Record last verified: 2008-11

Locations

US(4)