Logo 1 Logo 2

Clinical Trial Details

Trial ID: L7136
Source ID: NCT01106677
Associated Drug: Placebo
Title: The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01106677/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo|DRUG: Canagliflozin|DRUG: Sitagliptin|DRUG: Metformin immediate release
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 or sitagliptin 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 between each canagliflozin or sitagliptin group and placebo., 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 or sitagliptin group minus placebo) in the LS mean change., Day 1 (Baseline) and Week 26|Change in 2-hour Post-prandial Glucose From Baseline to Week 26, The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin 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 or sitagliptin group minus placebo) in the LS mean percent 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 or sitagliptin 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 or sitagliptin group minus placebo) in the LS mean percent 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 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change., Day 1 (Baseline) and Week 26|Change in HbA1c From Baseline to Week 52, The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change., Day 1 (Baseline) and Week 52|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52, The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change., Day 1 (Baseline) and Week 52|Percent Change in Body Weight From Baseline to Week 52, The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change., Day 1 (Baseline) and Week 52|Change in Systolic Blood Pressure (SBP) From Baseline to Week 52, The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change., Day 1 (Baseline) and Week 52|Percent Change in Triglycerides From Baseline to Week 52, The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change., Day 1 (Baseline) and Week 52|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52, The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change., Day 1 (Baseline) and Week 52
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1284
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-05
Completion Date: 2012-05
Results First Posted: 2013-07-30
Last Update Posted: 2013-07-30
Locations: Little Rock, Arkansas, United States|Fountain Valley, California, United States|National City, California, United States|Northridge, California, United States|Colorado Springs, Colorado, United States|Denver, Colorado, United States|Bradenton, Florida, United States|Brooksville, Florida, United States|Defuniak Springs, Florida, United States|Hialeah, Florida, United States|Niceville, Florida, United States|Tampa, Florida, United States|Atlanta, Georgia, United States|Savannah, Georgia, United States|Champaign, Illinois, United States|Avon, Indiana, United States|Fishers, Indiana, United States|Franklin, Indiana, United States|West Des Moines, Iowa, United States|Wichita, Kansas, United States|Munfordville, Kentucky, United States|Portland, Maine, United States|Benzonia, Michigan, United States|Interlochen, Michigan, United States|Troy, Michigan, United States|Picayune, Mississippi, United States|Florissant, Missouri, United States|Saint Louis, Missouri, United States|Las Vegas, Nevada, United States|Mansfield, New Jersey, United States|New Hyde Park, New York, United States|Asheboro, North Carolina, United States|Charlotte, North Carolina, United States|Kettering, Ohio, United States|Oregon City, Oregon, United States|Altoona, Pennsylvania, United States|Tipton, Pennsylvania, United States|East Providence, Rhode Island, United States|Greer, South Carolina, United States|Mount Pleasant, South Carolina, United States|Nashville, Tennessee, United States|New Braunfels, Texas, United States|San Antonio, Texas, United States|Bountiful, Utah, United States|Spokane, Washington, United States|Buenos Aires, Argentina|Mendoza, Argentina|San Juan, Argentina|Pleven, Bulgaria|Plovdiv, Bulgaria|Sevlievo, Bulgaria|Sofia, Bulgaria|Barranquilla, Colombia|Bogota, Colombia|Medellin, Colombia|Beroun, Czech Republic|Pardubice, Czech Republic|Plzen, Czech Republic|Rychnov Nad Kneznou, Czech Republic|Tabor, Czech Republic|Tallinn, Estonia|Piraeus, Greece|Thessalonikis, Greece|Ahmedabad, Gujarat, India|Aurangabad, India|Bangalore, Karnataka, India|Bangalore, India|Belgaum, India|Coimbatore, India|Mumbai, India|Nagpur, India|Pune, India|Trivandrum, India|Daugavpils, Latvia|Limbazi, Latvia|Riga, Latvia|Talsi, Latvia|Kelantan, Malaysia|Kuala Lumpur N/A, Malaysia|Kuala Lumpur, Malaysia|Pulau Pinang, Malaysia|Selangor, Malaysia|Culiacan, Mexico|Guadalajara, Mexico|Monterrey, Mexico|Queretaro, Mexico|Tampico, Mexico|Lima 1 Lima Lima, Peru|Leczyca, Poland|Lodz, Poland|Lublin, Poland|Wroclaw, Poland|Zgierz, Poland|Aveiro, Portugal|Leiria, Portugal|Lisboa, Portugal|Portalegre, Portugal|San Juan, Puerto Rico|Chelyabinsk, Russian Federation|Dzerzhinsky Moscow Region, Russian Federation|Ekaterinburg, Russian Federation|Kemerovo, Russian Federation|Penza, Russian Federation|Saint Petersburg, Russian Federation|St Petersburg, Russian Federation|St-Petersburg, Russian Federation|Singapore, Singapore|Banska Bystrica, Slovakia|Bratislava, Slovakia|Kosice, Slovakia|Sahy, Slovakia|Trebisov, Slovakia|Göteborg, Sweden|Stockholm, Sweden|Bangkok, Thailand|Chiang Mai, Thailand|Khon Kaen, Thailand|Ankara, Turkey|Antalya, Turkey|Istanbul, Turkey|Izmir, Turkey|Konya, Turkey|Donetsk, Ukraine|Ivano Frankivsk, Ukraine|Kiev, Ukraine|Sumy, Ukraine|Vinnitsa, Ukraine|Zaporozhye, Ukraine
URL: https://clinicaltrials.gov/show/NCT01106677