A Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-Weeks

NCT ID: NCT00427401

Last Updated: 2008-09-29

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PF-00915275 following administration to adult human subjects with T2DM for 4-weeks. The primary end point is glucose lowering (24 hour mean glucose concentration).

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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PF-00915275

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus
* HbA1c \> 7.5%.

Exclusion Criteria

* Recent (within the past 12 months) evidence or history of unstable concomitant disease.
* Treatment with any oral hypoglycemic agent within 3 months before enrollment.
* The exception to these criteria is that subjects who are currently taking metformin hydrochloride, in a stable dose (that is no changes in dose) for treatment of their diabetes within the past 3 months or longer of enrollment may participate.
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

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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Other Identifiers

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A8441003

Identifier Type: -

Identifier Source: org_study_id