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Clinical Trial Details

Trial ID: L7325
Source ID: NCT01106651
Associated Drug: Canagliflozin 100 Mg
Title: A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01106651/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Canagliflozin 100 mg|DRUG: Canagliflozin 300 mg|DRUG: Antihyperglycemic agent(s)|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|Percent Change in Body Weight From Baseline to Week 26, The table below shows the least-squares (LS) mean percent change in body weight 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|Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition, The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change., Day 1 (Baseline) and Week 26|Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition, Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change., Day 1 (Baseline) and Week 26|Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition, Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change., Day 1 (Baseline) and Week 26|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26, The table below shows the least-squares (LS) mean change in SBP 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|Percent Change in Triglycerides From Baseline to Week 26, The table below shows the least-squares (LS) mean percent change in triglycerides 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|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26, The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or 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|Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26, The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change., Day 1 (Baseline) and Week 26|Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26, The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change., Day 1 (Baseline) and Week 26|Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26, The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change., Day 1 (Baseline) and Week 26|Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26, The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change., Day 1 (Baseline) and Week 26
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 716
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-06
Completion Date: 2013-05
Results First Posted: 2013-05-29
Last Update Posted: 2014-11-04
Locations: Glendale, Arizona, United States|Phoenix, Arizona, United States|Little Rock, Arkansas, United States|Carmichael, California, United States|Citrus Heights, California, United States|Fair Oaks, California, United States|Roseville, California, United States|Sacramento, California, United States|San Diego, California, United States|Walnut Creek, California, United States|Daytona Beach, Florida, United States|Fleming Island, Florida, United States|Jacksonville, Florida, United States|Miami, Florida, United States|Atlanta, Georgia, United States|Wichita, Kansas, United States|Waltham, Massachusetts, United States|Pahrump, Nevada, United States|Albuquerque, New Mexico, United States|Cary, North Carolina, United States|Charlotte, North Carolina, United States|Wilmington, North Carolina, United States|Bismarck, North Dakota, United States|Franklin, Ohio, United States|Mount Pleasant, South Carolina, United States|Bristol, Tennessee, United States|Carrollton, Texas, United States|Dallas, Texas, United States|Irving, Texas, United States|Plano, Texas, United States|Richardson, Texas, United States|Renton, Washington, United States|Tacoma, Washington, United States|Wenatchee, Washington, United States|Fremantle, Australia|Heidelberg Heights, Australia|Meadowbrook, Australia|Richmond, Australia|Vancouver, British Columbia, Canada|St. John'S, Newfoundland and Labrador, Canada|Barrie, Ontario, Canada|London, Ontario, Canada|Markham, Ontario, Canada|Oakville, Ontario, Canada|Toronto, Ontario, Canada|Montreal, Quebec, Canada|Barranquilla, Colombia|Bogota, Colombia|Corbeil Essonnes, France|Paris, France|Venissieux, France|Thessalonikis, Greece|Thessaloniki, Greece|Sha Tin, Hong Kong|Bangalore, India|Nagpur, India|Pune, India|Auckland, New Zealand|Christchurch, New Zealand|Tauranga, New Zealand|Wellington, New Zealand|Katowice, Poland|Krakow, Poland|Torun, Poland|Warszawa, Poland|Wroclaw, Poland|Bucharest, Romania|Sibiu, Romania|Pretoria, South Africa|Granada, Spain|Madrid, Spain|Pozuelo De Alarcon, Spain|Sevilla, Spain|Göteborg, Sweden|Uppsala, Sweden|Bruderholz, Switzerland|St Gallen, Switzerland|Kharkov, Ukraine|Kiev, Ukraine|Birmingham, United Kingdom|Cardiff, United Kingdom|Glasgow, United Kingdom|Liverpool, United Kingdom|Manchester, United Kingdom|Reading, United Kingdom|Salford, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01106651