A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients

NCT ID: NCT01298518

Last Updated: 2012-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-05-31

Brief Summary

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PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.

Detailed Description

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Conditions

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Type 2 Diabetes Patients

Keywords

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multiple dose study in type 2 diabetes patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-04620110

Group Type EXPERIMENTAL

PF-04620110

Intervention Type DRUG

5 mg of PF-04620110 given once daily

PF-04620110

Intervention Type DRUG

2.5 mg of PF-04620110 given twice daily

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo giving for 4 weeks

Interventions

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PF-04620110

5 mg of PF-04620110 given once daily

Intervention Type DRUG

PF-04620110

2.5 mg of PF-04620110 given twice daily

Intervention Type DRUG

Placebo

Matching placebo giving for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and/or female subjects between the ages of 18 and 60 years;
* Body Mass Index (BMI) of \>25.0 kg/m2 and \<40 kg/m2;
* Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines;
* Subjects who have been on well-tolerated and stable doses of metformin

Exclusion Criteria

* Recent evidence (6 months prior to screening) or history of unstable major organ disease;
* Diagnosis of Type 1 diabetes mellitus;
* Current medical history of myocardial infarction, unstable angina, or history of stroke (including TIA) within 6 months prior to Screening;
* Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic agents;
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Chula Vista, California, United States

Site Status

Pfizer Investigational Site

DeLand, Florida, United States

Site Status

Pfizer Investigational Site

Miami Gardens, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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B0961007

Identifier Type: -

Identifier Source: org_study_id