| Trial ID: | L2093 |
| Source ID: | NCT02367131
|
| Associated Drug: |
Jardiance®
|
| Title: |
Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02367131/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: JARDIANCE®
|
| Outcome Measures: |
Primary: Percentage of Patients With Adverse Drug Reactions (ADRs), ADRs were defined as those adverse events for which the causal relationship was considered "Possibility high " or "Possibility low" or "Unknown" by the principal investigator, where: * Possibility high: There is a reasonable causal relationship between JARDIANCE® tablets administered and the adverse events (AE); * Possibility low: It is probably/possibly that there is a reasonable causal relationship between JARDIANCE® tablets administered and the AE; * Unknown: Cannot be judged because information is insufficient or contradictory. Percentages were rounded to two decimal places., From first drug administration until 7 days after last drug adminstration, up to 52 weeks. | Secondary: Change From Baseline in HbA1c (%) at the Last Observation During the Observation Period, Change from baseline in HbA1c (%) at the last observation during the observation period is reported. Change from baseline was calculated as: HbA1c value at the last observation - HbA1c baseline value., Baseline and last observation on treatment, up to week 52.|Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period, Change from baseline in fasting plasma glucose (FPG) at the last observation during the observation period. Change from baseline was calculated as: FPG value at the last observation - FPG baseline value., Baseline and last observation on treatment, up to week 52.
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
419
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2015-02-24
|
| Completion Date: |
2016-09-27
|
| Results First Posted: |
2018-06-20
|
| Last Update Posted: |
2024-03-08
|
| Locations: |
NISND Center, Multiple Locations, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02367131
|
