Clinical Trial Details
| Trial ID: | L5092 |
| Source ID: | NCT01340664 |
| Associated Drug: | Canagliflozin 50 Mg |
| Title: | An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01340664/results |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Canagliflozin 50 mg|DRUG: Placebo|DRUG: Canagliflozin 150 mg|DRUG: Metformin |
| Outcome Measures: | Primary: Change in HbA1c From Baseline to Week 18, The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 18 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 18 | Secondary: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18, The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 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 18|Percent Change in Body Weight From Baseline to Week 18, The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change., Day 1 (Baseline) and Week 18|Percentage of Patients With HbA1c <7% at Week 18, The table below shows the percentage of patients with HbA1c \<7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage., Week 18 |
| Sponsor/Collaborators: | Sponsor: Janssen Research & Development, LLC |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 279 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2011-07 |
| Completion Date: | 2012-04 |
| Results First Posted: | 2014-09-01 |
| Last Update Posted: | 2014-09-16 |
| Locations: | Little Rock, Arkansas, United States|National City, California, United States|Spring Valley, California, United States|Bradenton, Florida, United States|Marianna, Florida, United States|Savannah, Georgia, United States|Avon, Indiana, United States|Valparaiso, Indiana, United States|Madisonville, Kentucky, United States|Metairie, Louisiana, United States|Charlotte, North Carolina, United States|Columbus, Ohio, United States|Mason, Ohio, United States|Perrysburg, Ohio, United States|Tulsa, Oklahoma, United States|Yukon, Oklahoma, United States|Oregon City, Oregon, United States|Pittsburg, Pennsylvania, United States|East Providence, Rhode Island, United States|Nashville, Tennessee, United States|Houston, Texas, United States|Pearland, Texas, United States|San Antonio, Texas, United States|Bountiful, Utah, United States|Virginia Beach, Virginia, United States|Milwaukee, Wisconsin, United States|St. John'S, Newfoundland and Labrador, Canada|Halifax, Nova Scotia, Canada|Brampton, Ontario, Canada|Toronto, Ontario, Canada|Saskatoon, Saskatchewan, Canada|Beroun, Czech Republic|Olomouc 9, Czech Republic|Ostrava, Czech Republic|Pardubice, Czech Republic|Pisek, Czech Republic|Prague 10, Czech Republic|Praha 11, Czech Republic|Znojmo, Czech Republic|Aguascalientes, Mexico|Guadalajara, Jalisco., Mexico|Monterrey, Mexico|Tampico, Mexico|Bacau, Romania|Brasov, Romania|Bucharest, Romania|Cluj-Napoca, Romania|Galati, Romania|Targu Mures, Romania|Kursk, Russian Federation|Moscow, Russian Federation|Saint-Petersburg, Russian Federation|Samara, Russian Federation|Saratov, Russian Federation|St Petersburg, Russian Federation|St-Petersburg, Russian Federation|Tyumen, Russian Federation|Voronezh, Russian Federation|Banska Bystrica, Slovakia|Bratislava, Slovakia|Kosice, Slovakia|Presov, Slovakia|Sahy, Slovakia|Trebisov, Slovakia |
| URL: | https://clinicaltrials.gov/show/NCT01340664 |
