| Trial ID: | L5320 |
| Source ID: | NCT02489942
|
| Associated Drug: |
Jardiance
|
| Title: |
Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02489942/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Jardiance
|
| Outcome Measures: |
Primary: Number of Patients With Adverse Drug Reactions (ADRs), Number of patients with adverse drug reactions., From first drug administration until 7 days after last drug administration, up to 247 weeks. | Secondary: Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period, Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period., At start of treatment and at last observation on treatment, up to 246 weeks.|Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period, Change from baseline in fasting plasma glucose (FPG) at the last- observation during observation period., At start of treatment and at last observation on treatment, up to 246 weeks.
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
8145
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2015-06-12
|
| Completion Date: |
2020-12-04
|
| Results First Posted: |
2022-02-04
|
| Last Update Posted: |
2022-02-04
|
| Locations: |
Multiple Locations, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02489942
|
