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Clinical Trial Details

Trial ID: L6224
Source ID: NCT02025907
Associated Drug: Canagliflozin, 100 Mg
Title: A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02025907/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Canagliflozin, 100 mg|DRUG: Canagliflozin, 300 mg|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26, Baseline and Week 26 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26, Baseline and Week 26|Percent Change From Baseline in Body Weight at Week 26, Baseline and Week 26|Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26, Week 26|Change From Baseline in Systolic Blood Pressure (SBP) at Week 26, Baseline and Week 26
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 218
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-02
Completion Date: 2015-09
Results First Posted: 2016-09-02
Last Update Posted: 2016-10-31
Locations: Montgomery, Alabama, United States|Phoenix, Arizona, United States|Little Rock, Arkansas, United States|Northridge, California, United States|Norwalk, California, United States|Rancho Cucamonga, California, United States|San Ramon, California, United States|Aurora, Colorado, United States|Denver, Colorado, United States|Littleton, Colorado, United States|Cooper City, Florida, United States|Miami, Florida, United States|North Miami Beach, Florida, United States|Atlanta, Georgia, United States|Perry, Georgia, United States|Shawnee Mission, Kansas, United States|Marrero, Louisiana, United States|Metairie, Louisiana, United States|Metarie, Louisiana, United States|Rockville, Maryland, United States|Jackson, Mississippi, United States|Picayune, Mississippi, United States|Saint Louis, Missouri, United States|Nashua, New Hampshire, United States|Albuquerque, New Mexico, United States|Albany, New York, United States|Arlington, Texas, United States|San Antonio, Texas, United States|Sugarland, Texas, United States|Bountiful, Utah, United States|Coffs Harbour, Australia|Freemantle, Australia|Geelong, Australia|Heidelberg, Australia|Herston, Australia|Melbourne, Australia|Merewether, Australia|Sherwood, Australia|Sydney, Australia|Wollongong, Australia|Brampton, Ontario, Canada|Hawkesbury, Ontario, Canada|Toronto, Ontario, Canada|La Rochelle Cedex 1 Poitou-Cha, France|La Tronche, France|Nancy, France|Narbonne Cedex, France|Nice Cedex 3, France|Paris Cedex 15, France|Venissieux, France|Freiburg, Germany|Fulda, Germany|Hamburg, Germany|Münster, Germany|Neuwied, Germany|Pirna, Germany|Speyer, Germany
URL: https://clinicaltrials.gov/show/NCT02025907