| Trial ID: | L4778 |
| Source ID: | NCT02624908
|
| Associated Drug: |
Canagliflozin
|
| Title: |
Canagliflozin-Mealtime Insulin Rescue
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: canagliflozin|DRUG: placebo
|
| Outcome Measures: |
Primary: Number of patients who discontinue all pre-meal medications for at least one meal per day, 24 weeks|Number of patients who replace mealtime insulin with an oral agent for at least one meal per day, anti-hyperglycemic pill instead of insulin for at least one meal per day, 24 weeks|Number of patients with a continuing need for insulin 4 times per day, no change from the original basal -bolus regimen, 24 weeks|Frequency and severity of hypoglycemia, Hypoglycemic episodes will be evaluated using a hypoglycemia questionnaire, 24 weeks|Self monitoring and continuous monitoring blood glucose levels, glycemic control and glycemic variability, 24 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Foundation for Atlanta Veterans Education and Research, Inc. | Collaborators: Janssen Scientific Affairs, LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-01
|
| Completion Date: |
2022-12
|
| Results First Posted: |
|
| Last Update Posted: |
2022-08-15
|
| Locations: |
Atlanta VA Medical Center, Decatur, Georgia, 30033, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02624908
|
