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Clinical Trial Details

Trial ID: L3943
Source ID: NCT01137812
Associated Drug: Sitagliptin 100 Mg
Title: The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01137812/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Sitagliptin 100 mg|DRUG: Canagliflozin 300 mg|DRUG: Metformin|DRUG: Sulphonylurea
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 analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change., Day 1 (Baseline) and Week 52 | Secondary: Percentage of Patients With HbA1c <7% at Week 52, The table below shows the percentage of patients with HbA1c \<7% at Week 52 in each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the percentage., 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 treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and 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 treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and 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 treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and 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 mean percent change in triglycerides from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean 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 mean percent change in HDL-C from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change., Day 1 (Baseline) and Week 52
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 756
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-07
Completion Date: 2012-03
Results First Posted: 2013-05-17
Last Update Posted: 2015-01-15
Locations: Mobile, Alabama, United States|Goodyear, Arizona, United States|Mesa, Arizona, United States|Escondido, California, United States|Fresno, California, United States|Greenbrae, California, United States|La Mesa, California, United States|Laguna Hills, California, United States|Lancaster, California, United States|Long Beach, California, United States|Los Angeles, California, United States|Norwalk, California, United States|Pismo Beach, California, United States|Roseville, California, United States|Spring Valley, California, United States|Walnut Creek, California, United States|Watsonville, California, United States|Denver, Colorado, United States|Northglenn, Colorado, United States|Milford, Connecticut, United States|Bradenton, Florida, United States|Cape Coral, Florida, United States|Clearwater, Florida, United States|Delray Beach, Florida, United States|Miami, Florida, United States|Pembroke Pines, Florida, United States|Tampa, Florida, United States|Atlanta, Georgia, United States|Lewiston, Idaho, United States|Chicago, Illinois, United States|O'Fallon, Illinois, United States|Springfield, Illinois, United States|Topeka, Kansas, United States|Bowling Green, Kentucky, United States|Lexington, Kentucky, United States|Madisonville, Kentucky, United States|Baton Rouge, Louisiana, United States|Mandeville, Louisiana, United States|Metairie, Louisiana, United States|Sunset, Louisiana, United States|Brockton, Massachusetts, United States|Saint Clair Shores, Michigan, United States|Southfield, Michigan, United States|Dakota Dunes, Nebraska, United States|Toms River, New Jersey, United States|Albuquerque, New Mexico, United States|West Seneca, New York, United States|Calabash, North Carolina, United States|Greensboro, North Carolina, United States|Moerhead City, North Carolina, United States|Morganton, North Carolina, United States|Cincinnati, Ohio, United States|Gallipolis, Ohio, United States|Marion, Ohio, United States|Mason, Ohio, United States|Toledo, Ohio, United States|Zanesville, Ohio, United States|Beaver, Pennsylvania, United States|Bensalem, Pennsylvania, United States|Norristown, Pennsylvania, United States|Perryopolis, Pennsylvania, United States|Philadelphia, Pennsylvania, United States|Pittsburgh, Pennsylvania, United States|Pottstown, Pennsylvania, United States|Greenville, South Carolina, United States|Spartanburg, South Carolina, United States|Johnson City, Tennessee, United States|Dallas, Texas, United States|Fort Worth, Texas, United States|Houston, Texas, United States|Killeen, Texas, United States|Richardson, Texas, United States|San Antonio, Texas, United States|Schertz, Texas, United States|Sugar Land, Texas, United States|Burke, Virginia, United States|Danville, Virginia, United States|Falls Church, Virginia, United States|Hampton, Virginia, United States|Henrico, Virginia, United States|Manassas, Virginia, United States|Norfolk, Virginia, United States|Richmond, Virginia, United States|Selah, Washington, United States|Tacoma, Washington, United States|Salzburg, Austria|Wien, Austria|Hedersem (Aalst), Belgium|Tremelo, Belgium|Belem, Brazil|Brasilia, Brazil|Fortaleza, Brazil|Goiânia, Brazil|Marília, Brazil|Passo Fundo, Brazil|Porto Alegre, Brazil|Rio De Janeiro, Brazil|Sao Paulo, Brazil|Calgary, Alberta, Canada|Red Deer, Alberta, Canada|Vancouver, British Columbia, Canada|Halifax, Nova Scotia, Canada|Brampton, Ontario, Canada|Oshawa, Ontario, Canada|Toronto, Ontario, Canada|Charlottetown, Prince Edward Island, Canada|Sherbrooke, Quebec, Canada|Ville, Laint-Laurent, Quebec, Canada|Pointe-Claire, Canada|Toronto, Canada|Aalborg, Denmark|Ballerup, Denmark|Gentofte, Denmark|Vejle, Denmark|Vipperoed, Denmark|Bondy Cedex, France|Dijon, France|Marseille, France|Nantes, France|Narbonne Cedex, France|Paris, France|Pessac, France|St Etienne, France|Berlin, Germany|Dresden, Germany|Eisenach, Germany|Großheirath, Germany|Meißen, Germany|Bangalore, India|Coimbatore, India|Hyderabad, India|Jaipur, India|Nagpur, India|Nashik, India|Pune, India|Beer Sheba, Israel|Jerusalem, Israel|Kfar Saba, Israel|Nazareth, Israel|Rishon Lezion, Israel|Tel-Aviv, Israel|Busan, Korea, Republic of|Daegu, Korea, Republic of|Jeonju-Si, Korea, Republic of|Seongnam, Korea, Republic of|Seoul, Korea, Republic of|Ipoh, Malaysia|Johor Bahru, Malaysia|Kelantan, Malaysia|Selangor, Malaysia|Breda, Netherlands|Eindhoven, Netherlands|Groningen, Netherlands|Leiderdorp, Netherlands|Rotterdam, Netherlands|Velp Gld, Netherlands|Zoetermeer, Netherlands|Christchurch, New Zealand|Dunedin, New Zealand|Rotorua, New Zealand|Tauranga, New Zealand|Wellington, New Zealand|Bialystok, Poland|Chrzanow, Poland|Gdansk, Poland|Kamieniec Zabkowicki, Poland|Krakow, Poland|Lublin, Poland|Sobotka, Poland|Sopot, Poland|Torun, Poland|Wroclaw, Poland|Zabrze, Poland|Singapore, Singapore|Dnepropetrovsk, Ukraine|Ivano Frankivsk, Ukraine|Kharkov, Ukraine|Kiev, Ukraine|Odessa, Ukraine|Poltava, Ukraine|Sumy, Ukraine|Ternopil, Ukraine|Vinnitsa, Ukraine|Zaporozhye, Ukraine
URL: https://clinicaltrials.gov/show/NCT01137812