Clinical Trial Details
| Trial ID: | L6521 |
| Source ID: | NCT00642278 |
| Associated Drug: | Canagliflozin (Jnj-28431754) |
| Title: | An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00642278/results |
| Conditions: | Diabetes Mellitus, Type II|Diabetes Mellitus, Non Insulin Dependent |
| Interventions: | DRUG: Canagliflozin (JNJ-28431754)|DRUG: Sitagliptin|DRUG: Placebo |
| Outcome Measures: | Primary: Change in HbA1c From Baseline to Week 12, The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change., Day 1 (Baseline) and Week 12 | Secondary: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12, The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change., Day 1 (Baseline) and Week 12|Percentage of Patients With Symptoms of Hypoglycemia, The table below shows the percentage of patients who experienced symptomatic hypoglycemic events between Baseline and Week 12., Up to Week 12|Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12, The table below shows the mean change in overnight urine glucose/creatinine ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change., Day 1 (Baseline) and Week 12|Absolute Change in Body Weight From Baseline to Week 12, The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group., Day 1 (Baseline) and Week 12|Percent Change in Body Weight From Baseline to Week 12, The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change., Day 1 (Baseline) and Week 12 |
| Sponsor/Collaborators: | Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 451 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2008-04 |
| Completion Date: | 2009-01 |
| Results First Posted: | 2013-05-17 |
| Last Update Posted: | 2013-07-19 |
| Locations: | Birmingham, Alabama, United States|Mesa, Arizona, United States|Tucson, Arizona, United States|Encinitas, California, United States|Lincoln, California, United States|Los Angeles, California, United States|Merced, California, United States|Roseville, California, United States|Denver, Colorado, United States|Golden, Colorado, United States|Hollywood, Florida, United States|Jacksonville, Florida, United States|Boise, Idaho, United States|Nampa, Idaho, United States|Topeka, Kansas, United States|Haverhill, Massachusetts, United States|Cherry Hill, New Jersey, United States|Albuquerque, New Mexico, United States|New Hyde Park, New York, United States|Salisbury, North Carolina, United States|Oklahoma City, Oklahoma, United States|Tulsa, Oklahoma, United States|Portland, Oregon, United States|Greer, South Carolina, United States|Dallas, Texas, United States|Houston, Texas, United States|New Braunfels, Texas, United States|Odessa, Texas, United States|San Antonio, Texas, United States|Milwaukee, Wisconsin, United States|Buenos Aires, Argentina|Bueos Aires, Argentina|Pleven, Bulgaria|Sofia N/A, Bulgaria|Sofia, Bulgaria|Chilliwack, British Columbia, Canada|Coquitlam, British Columbia, Canada|Brampton, Ontario, Canada|Sarnia, Ontario, Canada|Toronto, Ontario, Canada|Pointe-Claire, Quebec, Canada|St Romuald, Quebec, Canada|Saskatoon, Saskatchewan, Canada|Olomouc 9, Czech Republic|Pisek 1, Czech Republic|Praha 28, Czech Republic|Praha 5, Czech Republic|Praha, Czech Republic|Bangalore, India|Hyderabad, India|Nagpur, India|Pune, India|Kota Bharu, Malaysia|Kuala Lumpur N/A, Malaysia|Kuala Lumpur, Malaysia|Ciudad De Mexico, Mexico|Mexico, Mexico|Monterrey, Mexico|Zapopan, Mexico|Bydgoszcz, Poland|Gdansk, Poland|Kutno 001, Poland|Lodz, Poland|Lublin N/A, Poland|Torun, Poland|Warszawa, Poland|Wroclaw, Poland|Ponce Pr, Puerto Rico|San Juan, Puerto Rico|Baia Mare, Romania|Brasov, Romania|Bucharest, Romania|Cluj, Romania|Galati, Romania|Ploiesti, Romania|Moscow N/A, Russian Federation|Moscow, Russian Federation|Saint Petersburg, Russian Federation|Samara, Russian Federation|St Petersburg N/A, Russian Federation|St-Petersburg, Russian Federation|Belfast, United Kingdom|Bolton, United Kingdom|Exeter, United Kingdom|Lincoln, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00642278 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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