NCT00618007

Brief Summary

To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving metformin

Trial Health

90
On Track

Trial Health Score

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

Enrollment
289

participants targeted

Target at P75+ for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_2 diabetes-mellitus-type-2

Geographic Reach
4 countries

79 active sites

Status
completed

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

Study Start

First participant enrolled

February 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

6 months

First QC Date

February 5, 2008

Last Update Submit

June 9, 2011

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    12 weeks

Secondary Outcomes (2)

  • Fasting Glucose

    12 weeks

  • Fasting Insulin

    12 weeks

Study Arms (3)

30 mg QD

EXPERIMENTAL
Drug: PF-00734200 30 mg QD

20 mg QD

EXPERIMENTAL
Drug: PF-00734200 20 mg QD

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-00734200 30 mg QDDRUG

30 mg QD

30 mg QD
PF-00734200 20 mg QDDRUG

20 mg QD

20 mg QD
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women between 18-80 years of age with poorly controlled Type 2 diabetes

You may not qualify if:

  • Type 1 or secondary forms of diabetes Currently using insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (79)

Pfizer Investigational Site

Birmingham, Alabama, 35205, United States

Location

Pfizer Investigational Site

Chandler, Arizona, 85225, United States

Location

Pfizer Investigational Site

Litchfield Park, Arizona, 85340, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85051, United States

Location

Pfizer Investigational Site

Artesia, California, 90701, United States

Location

Pfizer Investigational Site

Cerritos, California, 90703, United States

Location

Pfizer Investigational Site

Fresno, California, 93720, United States

Location

Pfizer Investigational Site

Greenbrea, California, 94904, United States

Location

Pfizer Investigational Site

Huntington Beach, California, 92648, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90057, United States

Location

Pfizer Investigational Site

National City, California, 91950, United States

Location

Pfizer Investigational Site

Roseville, California, 95661, United States

Location

Pfizer Investigational Site

Valley Village, California, 91607, United States

Location

Pfizer Investigational Site

West Covina, California, 91790, United States

Location

Pfizer Investigational Site

DeFuniak Springs, Florida, 32435, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32205, United States

Location

Pfizer Investigational Site

Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

Miami, Florida, 33169, United States

Location

Pfizer Investigational Site

New Port Richey, Florida, 34652, United States

Location

Pfizer Investigational Site

Ocala, Florida, 34471, United States

Location

Pfizer Investigational Site

Pinecrest, Florida, 33156, United States

Location

Pfizer Investigational Site

St. Petersburg, Florida, 33702, United States

Location

Pfizer Investigational Site

Conyers, Georgia, 30094, United States

Location

Pfizer Investigational Site

Idaho Falls, Idaho, 83404, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46260, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67203, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40504, United States

Location

Pfizer Investigational Site

Madisonville, Kentucky, 42431, United States

Location

Pfizer Investigational Site

Scarborough, Maine, 04074, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21204, United States

Location

Pfizer Investigational Site

Oxon Hill, Maryland, 20745, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48106, United States

Location

Pfizer Investigational Site

Bay City, Michigan, 48706, United States

Location

Pfizer Investigational Site

Canton, Michigan, 48187, United States

Location

Pfizer Investigational Site

Troy, Michigan, 48098, United States

Location

Pfizer Investigational Site

Jackson, Mississippi, 39209, United States

Location

Pfizer Investigational Site

Picayune, Mississippi, 39466, United States

Location

Pfizer Investigational Site

City of Saint Peters, Missouri, 63376, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63117, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63141, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89128, United States

Location

Pfizer Investigational Site

Elizabeth, New Jersey, 07202, United States

Location

Pfizer Investigational Site

Trenton, New Jersey, 08611, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87106, United States

Location

Pfizer Investigational Site

Syracuse, New York, 13210, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Pfizer Investigational Site

Marion, Ohio, 43302, United States

Location

Pfizer Investigational Site

Eugene, Oregon, 97401, United States

Location

Pfizer Investigational Site

Cumberland, Rhode Island, 02864, United States

Location

Pfizer Investigational Site

Aiken, South Carolina, 29801, United States

Location

Pfizer Investigational Site

Florence, South Carolina, 29501, United States

Location

Pfizer Investigational Site

Kingsport, Tennessee, 37660, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75235, United States

Location

Pfizer Investigational Site

El Paso, Texas, 79935, United States

Location

Pfizer Investigational Site

Houston, Texas, 77023, United States

Location

Pfizer Investigational Site

Houston, Texas, 77081, United States

Location

Pfizer Investigational Site

Hurst, Texas, 76054, United States

Location

Pfizer Investigational Site

Odessa, Texas, 79761, United States

Location

Pfizer Investigational Site

Pearland, Texas, 77584, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84107, United States

Location

Pfizer Investigational Site

Bennington, Vermont, 05201-5018, United States

Location

Pfizer Investigational Site

Ettrick, Virginia, 23803, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23225, United States

Location

Pfizer Investigational Site

Virginia Beach, Virginia, 23454, United States

Location

Pfizer Investigational Site

Virginia Beach, Virginia, 23455, United States

Location

Pfizer Investigational Site

Spokane, Washington, 99208, United States

Location

Pfizer Investigational Site

Kenosha, Wisconsin, 53142, United States

Location

Pfizer Investigational Site

Coquitlam, British Columbia, V3K 3P4, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M9W 4L6, Canada

Location

Pfizer Investigational Site

Laval, Quebec, H7T 2P5, Canada

Location

Pfizer Investigational Site

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Pfizer Investigational Site

Québec, Quebec, G1V 4M6, Canada

Location

Pfizer Investigational Site

San Juan, 00909-1711, Puerto Rico

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 120-752, South Korea

Location

Pfizer Investigational Site

Seoul, 135-710, South Korea

Location

Pfizer Investigational Site

Seoul, 136-705, South Korea

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

gosogliptin

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 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 18, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

PR(1)KR(4)US(69)CA(5)