Clinical trial NCT01338870: Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
Official title: A 12-week, Phase 2, Randomized, Double-blind, Placebo Controlled, Dose-ranging, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Pf-04991532 and Once Daily Sitagliptin in Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 2
safety and efficacy study with PF-04991532
Type 2 diabetes
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-04-20
Enrollment: 301
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: B2611003 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 6 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% Gain in Body Weight From Baseline
timeFrame: Week 12
measure: Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline
timeFrame: Week 12
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Roseville
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Coral Gables
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lake Charles
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Auburn
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Brooklyn Center
country: United States
facility: Pfizer Investigational Site
state: Minnesota
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: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Lansdale
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Katy
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Surrey
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Bay Roberts
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Mirabel
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Balatonfured
country: Hungary
facility: Pfizer Investigational Site
city: Kistelek
country: Hungary
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Tlalnepantla
country: Mexico
facility: Pfizer Investigational Site
state: Estado de Mexico
city: Aguascalientes
country: Mexico
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Nove Mesto nad Vahom
country: Slovakia
facility: Pfizer Investigational Site
city: Pezinok
country: Slovakia
facility: Pfizer Investigational Site
city: Presov
country: Slovakia
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taoyuan County
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: