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Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus

NCT ID: NCT01336738

Last Updated: 2013-08-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-03-31

Brief Summary

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B2611002 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 5 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.

Detailed Description

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Conditions

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Diabetes, Type 2

Keywords

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Phase 2 safety and efficacy study with PF-04991532 Type 2 diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Matching placebo for PF-04991532 and Sitagliptin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets (n=6), 0 mg, once daily for 84 days

150 mg PF-04991532

Group Type EXPERIMENTAL

150 mg PF-04991532

Intervention Type DRUG

Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days

450 mg PF-04991532

Group Type EXPERIMENTAL

450 mg PF-04991532

Intervention Type DRUG

Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days

750 mg PF-04991532

Group Type EXPERIMENTAL

750 mg PF-04991532

Intervention Type DRUG

Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days

Sitagliptin 100 mg

Group Type ACTIVE_COMPARATOR

Sitagliptin 100 mg

Intervention Type DRUG

Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days

Interventions

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Placebo

Tablets (n=6), 0 mg, once daily for 84 days

Intervention Type DRUG

150 mg PF-04991532

Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days

Intervention Type DRUG

450 mg PF-04991532

Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days

Intervention Type DRUG

750 mg PF-04991532

Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days

Intervention Type DRUG

Sitagliptin 100 mg

Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

Exclusion Criteria

Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.
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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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

Jonesboro, Arkansas, United States

Site Status

Pfizer Investigational Site

Jonesboro, Arkansas, United States

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Pfizer Investigational Site

Los Angeles, California, United States

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Pfizer Investigational Site

Palm Springs, California, United States

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Pfizer Investigational Site

Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Pfizer Investigational Site

West Palm Beach, Florida, United States

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Pfizer Investigational Site

Conyers, Georgia, United States

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Pfizer Investigational Site

Chicago, Illinois, United States

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Louisville, Kentucky, United States

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Fall River, Massachusetts, United States

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Brooklyn, New York, United States

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Cary, North Carolina, United States

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Wilmington, North Carolina, United States

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Columbus, Ohio, United States

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East Providence, Rhode Island, United States

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East Providence, Rhode Island, United States

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Mt. Pleasant, South Carolina, United States

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Bristol, Tennessee, United States

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Kingsport, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Kenosha, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Winnipeg, Manitoba, Canada

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Strathroy, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Laval, Quebec, Canada

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Saint Romuald, Quebec, Canada

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Budapest, , Hungary

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Pfizer Investigational Site

Guadalajara, Jalisco, Mexico

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Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Pfizer Investigational Site

Bratislava, , Slovakia

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Tainan City, , Taiwan

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Pfizer Investigational Site

Taipei, , Taiwan

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Countries

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United States Canada Hungary Mexico Slovakia South Korea Taiwan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2611002&StudyName=Study%20Of%20Safety%20And%20Efficacy%20Of%20PF-04991532%20In%20Subjects%20With%20Type%202%20Diabetes%20Mellitus

To obtain contact information for a study center near you, click here.

Other Identifiers

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B2611002

Identifier Type: -

Identifier Source: org_study_id