Clinical trial NCT00473525: 12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin
Official title: A Phase 2a, Randomized, Placebo-Controlled, Parallel Group, Multiple-Dose Study To Evaluate The Efficacy, Safety, And Tolerability Of 12-Week Oral Administration Of PF-00734200 Tablets To Subjects With Type 2 Diabetes Mellitus On Stable Treatment With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-15
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Hb1AC \>7%-11% inclusive
* Male and females 18-70; females must be post-menopausal
* On a stable dose of metformin hydrochloride

Exclusion Criteria:

* Medical history of stroke, unstable angina, heart attack within one year of enrollment, and alcohol dependency or recent drug abuse.
* Women of childbearing potential, pregnant or nursing
* Evidence of diabetic complications with significant end-organ damage

Primary outcomes:
measure: HbA1C levels (%)
timeFrame: 12 weeks
measure: Evaluation of Dose Response in HbA1c (%)
timeFrame: 12 weeks
Secondary outcomes:
measure: Insulin and Glucose AUC following a mixed meal tolerance test
timeFrame: 12 weeks
measure: Proportion of subjects achieving ADA glycemic goal of Hb A1c <7%
timeFrame: 12 weeks
measure: Incidence of Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Gilbert
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Carmichael
country: United States
facility: Pfizer Investigational Site
state: California
city: Chula Vista
country: United States
facility: Pfizer Investigational Site
state: California
city: Fair Oaks
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: National City
country: United States
facility: Pfizer Investigational Site
state: California
city: Paramount
country: United States
facility: Pfizer Investigational Site
state: California
city: Roseville
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: DeFuniak Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Destin
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Conyers
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Wheeling
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Brockton
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Canton
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Flint
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Biloxi
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Picayune
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Trenton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Marion
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Carnegie
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Bartlett
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Collierville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Irving
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Floridablanca
country: Colombia
facility: Pfizer Investigational Site
state: Santander
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Giengen
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Santiago de Compostela
country: Spain
facility: Pfizer Investigational Site
state: La Coruña
city: Alcala de Henares
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: