| Trial ID: | L5404 |
| Source ID: | NCT01381900
|
| Associated Drug: |
Placebo
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| Title: |
A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01381900/results
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| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: Placebo|DRUG: Canagliflozin 100mg|DRUG: Canagliflozin 300mg|DRUG: Metformin|DRUG: Sulphonylurea
|
| Outcome Measures: |
Primary: Change in Glycosylated Hemoglobin (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 Glycosylated Hemoglobin (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., Day 1 (Baseline) and Week 18|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18, The table below shows the percentage of patients with HbA1c \<6.5% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage., Day 1 (Baseline) and Week 18
|
| Sponsor/Collaborators: |
Sponsor: Janssen Research & Development, LLC
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
|
| Enrollment: |
678
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-08
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| Completion Date: |
2012-11
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| Results First Posted: |
2014-01-09
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| Last Update Posted: |
2014-05-09
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| Locations: |
Baotou, China|Beijing, China|Changchun, China|Changsha, China|Chengdu, China|Chongqing, China|Guangzhou, China|Hangzhou, China|Harbin, China|Nanchang, China|Nanjing, China|Nanning, China|Shanghai, China|Shenyang, China|Shiyan, China|Siping, China|Su Zhou, China|Tianjin, China|Wuxi, China|Xi'An, China|Kota Bharu, Malaysia|Pulau Pinang, Malaysia|Selangor, Malaysia|Hanoi, Vietnam|Ho Chi Minh, Vietnam
|
| URL: |
https://clinicaltrials.gov/show/NCT01381900
|
