Clinical trial NCT01336738: Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
Official title: A 12-Week, Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Efficacy And Safety Of Once Daily Pf-04991532 And Sitagliptin In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes, Type 2
Keywords: Phase 2
safety and efficacy study with PF-04991532
Type 2 diabetes
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 266
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: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8, 12
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
timeFrame: Baseline, Week 1, 2, 4, 8
measure: Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
timeFrame: Week 12
measure: Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8, 12
measure: Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline
timeFrame: Week 12
measure: Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline
timeFrame: Week 12
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Palm Springs
country: United States
facility: Pfizer Investigational Site
state: California
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Conyers
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Fall River
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: East Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: East Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bristol
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: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Kenosha
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Strathroy
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Thornhill
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St-Romuald
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: