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Clinical Trial Details

Trial ID: L5561
Source ID: NCT01338870
Associated Drug: Placebo
Title: Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01338870/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo|DRUG: 25 mg PF-04991532|DRUG: 75 mg PF-04991532|DRUG: 150 mg PF-04991532|DRUG: 300 mg PF-04991532|DRUG: Sitagliptin 100 mg
Outcome Measures: Primary: 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: 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, 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., 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., 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., 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, 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., 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., Week 12
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 301
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-06
Completion Date: 2012-03
Results First Posted: 2013-04-23
Last Update Posted: 2013-04-23
Locations: 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, Quebec, G3K 2P8, Canada|Pfizer Investigational Site, Balatonfured, 8230, Hungary|Pfizer Investigational Site, Kistelek, 6760, Hungary|Pfizer Investigational Site, Mexico, DF, 06700, Mexico|Pfizer Investigational Site, Tlalnepantla, Estado de Mexico, 54055, Mexico|Pfizer Investigational Site, Aguascalientes, 20234, Mexico|Pfizer Investigational Site, Bratislava, 851 01, Slovakia|Pfizer Investigational Site, Nove Mesto nad Vahom, 915 01, Slovakia|Pfizer Investigational Site, Pezinok, 902 01, Slovakia|Pfizer Investigational Site, Presov, 080 01, Slovakia|Pfizer Investigational Site, Taichung, 40705, Taiwan|Pfizer Investigational Site, Taoyuan County, 333, Taiwan
URL: https://clinicaltrials.gov/show/NCT01338870