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Clinical Trial Details

Trial ID: L4795
Source ID: NCT01336738
Associated Drug: Placebo
Title: Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01336738/results
Conditions: Diabetes, Type 2
Interventions: DRUG: Placebo|DRUG: 150 mg PF-04991532|DRUG: 450 mg PF-04991532|DRUG: 750 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% 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., 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., Week 12
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 266
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: 2013-08-06
Last Update Posted: 2013-08-06
Locations: Pfizer Investigational Site, Jonesboro, Arkansas, 72401, United States|Pfizer Investigational Site, Jonesboro, Arkansas, 72404, United States|Pfizer Investigational Site, Los Angeles, California, 90057, United States|Pfizer Investigational Site, Palm Springs, California, 92262, United States|Pfizer Investigational Site, Jacksonville, Florida, 32216, United States|Pfizer Investigational Site, Melbourne, Florida, 32901, United States|Pfizer Investigational Site, West Palm Beach, Florida, 33401, United States|Pfizer Investigational Site, Conyers, Georgia, 30094, United States|Pfizer Investigational Site, Chicago, Illinois, 60607, United States|Pfizer Investigational Site, Louisville, Kentucky, 40213, United States|Pfizer Investigational Site, Fall River, Massachusetts, 02720, United States|Pfizer Investigational Site, Brooklyn, New York, 11230, United States|Pfizer Investigational Site, Cary, North Carolina, 27518, United States|Pfizer Investigational Site, Wilmington, North Carolina, 28401, United States|Pfizer Investigational Site, Columbus, Ohio, 43213, United States|Pfizer Investigational Site, East Providence, Rhode Island, 02914, United States|Pfizer Investigational Site, East Providence, Rhode Island, 02915, United States|Pfizer Investigational Site, Mount Pleasant, South Carolina, 29464, United States|Pfizer Investigational Site, Bristol, Tennessee, 37620, United States|Pfizer Investigational Site, Kingsport, Tennessee, 37660, United States|Pfizer Investigational Site, Dallas, Texas, 75230, United States|Pfizer Investigational Site, Houston, Texas, 77036, United States|Pfizer Investigational Site, Houston, Texas, 77074, United States|Pfizer Investigational Site, Houston, Texas, 77081, United States|Pfizer Investigational Site, San Antonio, Texas, 78229, United States|Pfizer Investigational Site, Charlottesville, Virginia, 22911, United States|Pfizer Investigational Site, Kenosha, Wisconsin, 53142, United States|Pfizer Investigational Site, Milwaukee, Wisconsin, 53209, United States|Pfizer Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|Pfizer Investigational Site, Strathroy, Ontario, N7G 1Y7, Canada|Pfizer Investigational Site, Thornhill, Ontario, L4J 8L7, Canada|Pfizer Investigational Site, Toronto, Ontario, M9W 4L6, Canada|Pfizer Investigational Site, Laval, Quebec, H7T 2P5, Canada|Pfizer Investigational Site, St-Romuald, Quebec, G6W 5M6, Canada|Pfizer Investigational Site, Budapest, 1036, Hungary|Pfizer Investigational Site, Seoul, 110-744, Korea, Republic of|Pfizer Investigational Site, Seoul, 120-752, Korea, Republic of|Pfizer Investigational Site, Seoul, 138-736, Korea, Republic of|Pfizer Investigational Site, Guadalajara, Jalisco, 44130, Mexico|Pfizer Investigational Site, Guadalajara, Jalisco, 44650, Mexico|Pfizer Investigational Site, Monterrey, Nuevo Leon, 64460, Mexico|Pfizer Investigational Site, Bratislava, 831 01, Slovakia|Pfizer Investigational Site, Tainan, 710, Taiwan|Pfizer Investigational Site, Taipei, 100, Taiwan
URL: https://clinicaltrials.gov/show/NCT01336738