Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
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
1 other identifier
interventional
301
6 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Jun 2011
Shorter than P25 for phase_2 diabetes-mellitus-type-2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2011
CompletedFirst Posted
Study publicly available on registry
April 20, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
April 23, 2013
CompletedApril 23, 2013
March 1, 2013
9 months
April 13, 2011
March 11, 2013
March 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Baseline, Week 12
Secondary Outcomes (6)
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Baseline, Week 1, 2, 4, 8
Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
Week 12
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Baseline, Week 1, 2, 4, 8, 12
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline
Week 12
- +1 more secondary outcomes
Study Arms (6)
Placebo
PLACEBO COMPARATORPlacebo for PF-04991532 and sitagliptin
25 mg PF-04991532
EXPERIMENTAL75 mg PF-04991532
EXPERIMENTAL150 mg PF-04991532
EXPERIMENTAL300 mg PF-04991532
EXPERIMENTALSitagliptin 100 mg
ACTIVE COMPARATORInterventions
Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days
Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days
Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days
Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days
Tablets (n=1), 100 mg strength + tablets (n=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening for 84 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (42)
Pfizer Investigational Site
Little Rock, Arkansas, 72205, United States
Pfizer Investigational Site
Roseville, California, 95661, United States
Pfizer Investigational Site
Denver, Colorado, 80209, United States
Pfizer Investigational Site
Coral Gables, Florida, 33134, United States
Pfizer Investigational Site
Ocala, Florida, 34471, United States
Pfizer Investigational Site
Honolulu, Hawaii, 96814, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46260, United States
Pfizer Investigational Site
Augusta, Kansas, 67010, United States
Pfizer Investigational Site
Overland Park, Kansas, 66215, United States
Pfizer Investigational Site
Wichita, Kansas, 67207, United States
Pfizer Investigational Site
Lexington, Kentucky, 40504, United States
Pfizer Investigational Site
Lake Charles, Louisiana, 70601, United States
Pfizer Investigational Site
Auburn, Maine, 04210, United States
Pfizer Investigational Site
Brooklyn Center, Minnesota, 55430, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89101, United States
Pfizer Investigational Site
Trenton, New Jersey, 08611, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28277, United States
Pfizer Investigational Site
Fargo, North Dakota, 58103, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45245, United States
Pfizer Investigational Site
Lansdale, Pennsylvania, 19446, United States
Pfizer Investigational Site
Dallas, Texas, 75246, United States
Pfizer Investigational Site
Katy, Texas, 77450, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Norfolk, Virginia, 23502, United States
Pfizer Investigational Site
Richmond, Virginia, 23294, United States
Pfizer Investigational Site
Surrey, British Columbia, V4A 2H9, Canada
Pfizer Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada
Pfizer Investigational Site
Brampton, Ontario, L6T 0G1, Canada
Pfizer Investigational Site
Mississauga, Ontario, L4Y 2N8, Canada
Pfizer Investigational Site
Mirabel, Quebec, J7J 2K8, Canada
Pfizer Investigational Site
Québec, Quebec, G3K 2P8, Canada
Pfizer Investigational Site
Balatonfüred, 8230, Hungary
Pfizer Investigational Site
Kistelek, 6760, Hungary
Pfizer Investigational Site
Aguascalientes, Aguascalientes, 20234, Mexico
Pfizer Investigational Site
Mexico City, Mexico City, 06700, Mexico
Pfizer Investigational Site
Tlalnepantla, State of Mexico, 54055, Mexico
Pfizer Investigational Site
Bratislava, 851 01, Slovakia
Pfizer Investigational Site
Nové Mesto nad Váhom, 915 01, Slovakia
Pfizer Investigational Site
Pezinok, 902 01, Slovakia
Pfizer Investigational Site
Prešov, 080 01, Slovakia
Pfizer Investigational Site
Taichung, 40705, Taiwan
Pfizer Investigational Site
Taoyuan, 333, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2011
First Posted
April 20, 2011
Study Start
June 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
April 23, 2013
Results First Posted
April 23, 2013
Record last verified: 2013-03