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Clinical Trial Details

Trial ID: L4828
Source ID: NCT01064414
Associated Drug: Canagliflozin
Title: An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01064414/results
Conditions: Diabetes Mellitus, Type 2|Renal Insufficiency
Interventions: DRUG: Canagliflozin|DRUG: Placebo
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 26, The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change., Day 1 (Baseline) and Week 26 | Secondary: Percentage of Patients With HbA1c <7% at Week 26, The table below shows the percentage of patients with HbA1c \<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage., Week 26|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26, The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change., Day 1 (Baseline) and Week 26
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 272
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2010-06
Completion Date: 2012-08
Results First Posted: 2013-05-27
Last Update Posted: 2013-08-14
Locations: Concord, California, United States|Fountain Valley, California, United States|San Diego, California, United States|Denver, Colorado, United States|Pembroke Pines, Florida, United States|Tampa, Florida, United States|West Palm Beach, Florida, United States|Augusta, Georgia, United States|Nampa, Idaho, United States|Baton Rouge, Louisiana, United States|Jackson, Mississippi, United States|Picayune, Mississippi, United States|Chesterfield, Missouri, United States|Las Vegas, Nevada, United States|Albuquerque, New Mexico, United States|Durham, North Carolina, United States|Canal Fulton, Ohio, United States|Cincinnati, Ohio, United States|Columbus, Ohio, United States|Zanesville, Ohio, United States|Oklahoma City, Oklahoma, United States|Meridian, Pennsylvania, United States|Pittsburgh, Pennsylvania, United States|North Charleston, South Carolina, United States|Salt Lake City, Utah, United States|Fairfax, Virginia, United States|Camperdown, Australia|Gosford, Australia|Parkville, Australia|Reservoir, Australia|Aalst, Belgium|Bonheiden, Belgium|Brussels, Belgium|Liège, Belgium|Sint-Niklaas, Belgium|Turnhout, Belgium|Sao Paulo, Brazil|São Paulo, Brazil|Vancouver, British Columbia, Canada|Victoria, British Columbia, Canada|Antigonish, Nova Scotia, Canada|Sydney, Nova Scotia, Canada|Hamilton, Ontario, Canada|London, Ontario, Canada|Smiths Falls, Ontario, Canada|Thornhill, Ontario, Canada|Montreal, Quebec, Canada|Calgary, Canada|Corbeil Essonnes, France|La Rochelle Cedex 1 Poitou-Cha, France|Le Creusot, France|Nantes N/A, France|Pierre Benite, France|Vandoeuvre Les Nancy, France|Venissieux, France|Dormagen, Germany|Dortmund, Germany|Dresden, Germany|Einbeck, Germany|Freiburg, Germany|Kassel, Germany|München, Germany|Schkeuditz, Germany|Würzburg, Germany|Aurangabad, India|Madurai, India|Pune, India|Seognam-Si, Kyungki-Do, Korea, Republic of|Seoul, Korea, Republic of|Daugavpils, Latvia|Ogre, Latvia|Riga, Latvia|Jalan Cheras N/A, Malaysia|Kajang, Malaysia|Kuala Lumpur N/A, Malaysia|Pulau Pinang, Malaysia|Aguascalientes, Mexico|Culiacan, Mexico|Morelia, Mexico|Zapopan, Mexico|Auckland, New Zealand|Christchurch, New Zealand|Dunedin Nz, New Zealand|Nz, New Zealand|Lask, Poland|Lublin, Poland|Warszawa, Poland|Bucharest, Romania|Targoviste, Romania|Chelyabinsk, Russian Federation|Kirov, Russian Federation|Kursk, Russian Federation|Moscow, Russian Federation|Nizhny Novgorod, Russian Federation|Petrozavodsk, Russian Federation|Rostov-On-Don, Russian Federation|Saint Petersburg, Russian Federation|St Petersburg, Russian Federation|Yaroslavl, Russian Federation|Parow, Cape Town, South Africa|Pretoria, South Africa|Somerset West, South Africa|Barcelona, Spain|Ciudad Real, Spain|Madrid N/A, Spain|Madrid, Spain|San Sebastian De Los Reyes, Spain|Santa Cruz De Tenerife, Spain|Valencia, Spain
URL: https://clinicaltrials.gov/show/NCT01064414

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress