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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
301
Tablets (n=4), 0 mg twice daily for 84 days
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
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.
Time frame: Baseline, Week 12
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Time frame: Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
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% 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.
Time frame: Baseline, Week 1, 2, 4, 8
Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
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% 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.
Time frame: Week 12
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.
Time frame: Baseline, Week 1, 2, 4, 8, 12
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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.
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Roseville, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Coral Gables, Florida, United States
Pfizer Investigational Site
Ocala, Florida, United States
Pfizer Investigational Site
Honolulu, Hawaii, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
Augusta, Kansas, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Wichita, Kansas, United States
...and 32 more locations
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline
Overweight or obesity increases the risk for developing diabetes. Participants with \>= 1% or \>= 2% gain in body weight from baseline signifies a higher risk of diabetes.
Time frame: Week 12
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline
The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with \>= 1% or \>= 2% loss in body weight from baseline signifies an improvement of glycemia.
Time frame: Week 12