Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects

NCT ID: NCT00638313

Last Updated: 2009-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-02-29

Brief Summary

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PF 04603629 is a long acting exendin proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and glucose lowering capabilities following a single subcutaneous dose.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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GLP-1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Subjects will be given either Placebo or PF-04603629.

PF-04603629

Group Type EXPERIMENTAL

PF-04603629

Intervention Type BIOLOGICAL

Subjects will be given either Placebo or PF-04603629. The specific dose of PF-04603629 given depended on the Cohort to which the patient was assigned. Doses administered ranged from 1 mg to 70 mg.

Interventions

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Placebo

Subjects will be given either Placebo or PF-04603629.

Intervention Type BIOLOGICAL

PF-04603629

Subjects will be given either Placebo or PF-04603629. The specific dose of PF-04603629 given depended on the Cohort to which the patient was assigned. Doses administered ranged from 1 mg to 70 mg.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus
* Hb A1c lower or equal to 11%

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Evidence of diabetic complications with significant end-organ damage
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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B0571001

Identifier Type: -

Identifier Source: org_study_id