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Clinical Trial Details

Trial ID: L3668
Source ID: NCT00968812
Associated Drug: Glimepiride
Title: CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00968812/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Glimepiride|DRUG: Canagliflozin (JNJ-28431754)|DRUG: Metformin
Outcome Measures: Primary: 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 treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change., Day 1 (Baseline) and Week 52 | Secondary: Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52, The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages., 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 treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change., Day 1 (Baseline) and Week 52|Change in HbA1c From Baseline to Week 104, The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change., Baseline, Week 104
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1452
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-09
Completion Date: 2013-01
Results First Posted: 2013-06-04
Last Update Posted: 2017-01-30
Locations: Calera, Alabama, United States|Gilbert, Arizona, United States|Mesa, Arizona, United States|Tucson, Arizona, United States|Jonesboro, Arkansas, United States|Buena Park, California, United States|Encinitas, California, United States|Fresno, California, United States|Lincoln, California, United States|Roseville, California, United States|San Diego, California, United States|Westlake Village, California, United States|Chipley, Florida, United States|Marianna, Florida, United States|Oldsmar, Florida, United States|Orlando, Florida, United States|Augusta, Georgia, United States|Perry, Georgia, United States|Nampa, Idaho, United States|Chicago, Illinois, United States|Vernon Hills, Illinois, United States|Valparaiso, Indiana, United States|New Orleans, Louisiana, United States|Elkridge, Maryland, United States|Bloomfield Hills, Michigan, United States|Las Vegas, Nevada, United States|Canal Fulton, Ohio, United States|Gallipolis, Ohio, United States|Mason, Ohio, United States|Perrysburg, Ohio, United States|Tulsa, Oklahoma, United States|Yukon, Oklahoma, United States|Fleetwood, Pennsylvania, United States|Greenville, South Carolina, United States|Nashville, Tennessee, United States|Houston, Texas, United States|Odessa, Texas, United States|Pearland, Texas, United States|San Antonio, Texas, United States|Danville, Virginia, United States|Olympia, Washington, United States|Milwaukee, Wisconsin, United States|Wauwatosa, Wisconsin, United States|Buenos Aires, Argentina|Ciudad Autonoma De Buenos Aires, Argentina|Mar Del Plata, Argentina|Rosario, Argentina|Dimitrovgrad, Bulgaria|Kazanlak, Bulgaria|Rousse, Bulgaria|Sofia, Bulgaria|Chilliwack, British Columbia, Canada|Kelowna, British Columbia, Canada|Vancouver, British Columbia, Canada|St. John'S, Newfoundland and Labrador, Canada|Mississauga, Ontario, Canada|Toronto, Ontario, Canada|Saskatoon, Saskatchewan, Canada|Quebec, Canada|San Jose, Costa Rica|San Pedro, Costa Rica|Aalborg, Denmark|Ballerup, Denmark|Vejle, Denmark|Vipperoed, Denmark|Helsinki, Finland|Kokkola, Finland|Kuopio, Finland|Oulu, Finland|Turku, Finland|Berlin, Germany|Dresden, Germany|Duesseldorf, Germany|Hamburg, Germany|Mainz, Germany|Villingen-Schwenningen, Germany|Bangalore, India|Chennai, India|Coimbatore, India|Hyderabad, India|Nagpur, India|Pune, India|Wardha, India|Beer Sheba, Israel|Haifa, Israel|Holon, Israel|Jerusalem, Israel|Ramat Gan, Israel|Rehovot, Israel|Tel Aviv, Israel|Tel-Aviv, Israel|Zefat, Israel|Daegu, Korea, Republic of|Goyang-Si, Korea, Republic of|Gyeonggi-Do, Korea, Republic of|Incheon, Korea, Republic of|Seoul, Korea, Republic of|Suwon, Korea, Republic of|Wonju-Si, Korea, Republic of|Wonju, Korea, Republic of|Ciudad De Mexico, Mexico|Mexico, Mexico|Monterrey, Mexico|Alesund, Norway|Oslo, Norway|Cebu, Philippines|Marikina City, Philippines|Pasay, Philippines|Quezon City, Philippines|Bydgoszcz, Poland|Krakow, Poland|Kutno 001, Poland|Lodz, Poland|Lublin, Poland|Torun, Poland|Warszawa, Poland|Wroclaw, Poland|Zielona Gora, Poland|Ponce, Puerto Rico|Baia Mare, Romania|Brasov, Romania|Bucharest, Romania|Cluj, Romania|Galati, Romania|Ploiesti, Romania|Targu Mures, Romania|Arkhangelsk, Russian Federation|Moscow, Russian Federation|Saint Petersburg, Russian Federation|Samara, Russian Federation|Saratov, Russian Federation|St Petersburg, Russian Federation|Banska Bystrica, Slovakia|Bratislava, Slovakia|Lubochna, Slovakia|Presov, Slovakia|Dnepropetrovsk, Ukraine|Kharkov, Ukraine|Kiev, Ukraine|Poltava, Ukraine|Ternopil, Ukraine|Vinnitsa, Ukraine
URL: https://clinicaltrials.gov/show/NCT00968812

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details