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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
266
Tablets (n=6), 0 mg, once daily for 84 days
Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days
Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once 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=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days
Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days
Pfizer Investigational Site
Jonesboro, Arkansas, United States
Pfizer Investigational Site
Jonesboro, Arkansas, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Palm Springs, California, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Melbourne, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
Pfizer Investigational Site
Conyers, Georgia, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
...and 34 more locations
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline
Overweight or obesity increases the risk for developing diabetes. Participants with \>= 1% or \>= 2% body weight gain from baseline signifies a higher risk of diabetes.
Time frame: Week 12
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss 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% body weight loss from baseline signifies an improvement of glycemia.
Time frame: Week 12