| Trial ID: | L5822 |
| Source ID: | NCT01128985
|
| Associated Drug: |
Canagliflozin 50 Mg
|
| Title: |
A Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Canagliflozin 50 mg|DRUG: Canagliflozin 100 mg|DRUG: Canagliflozin 300 mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: The concentration of canagliflozin and major metabolites (M5 and M7) in blood will be measured by protocol-specified pharmacokinetic parameters., At protocol-specified time points through Day 7 | Secondary: The relationship between the concentration of glucose in patient blood measured by protocol-specified pharmacodynamic parameters, At protocol-specified time points from baseline to Day 7|The safety and tolerability of canagliflozin will be determined by monitoring adverse events and findings from laboratory evaluations, vital signs measurements, and ECG measurements reported., At protocol-specified time points from the time of screening (Day -44 to Day -23) to end-of-study (7 to 10 days after Day 7 or at the time of early withdrawal from the study)
|
| Sponsor/Collaborators: |
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
39
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-03
|
| Completion Date: |
2010-07
|
| Results First Posted: |
|
| Last Update Posted: |
2013-05-29
|
| Locations: |
Fort Myers, Florida, United States|Miramar, Florida, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01128985
|
