N/A
N=419
Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02367131 ↗Enrolled (actual)
419
Serious AEs
1.5%
Results posted
Jun 2018
Primary outcome: Primary: Percentage of Patients With Adverse Drug Reactions (ADRs) — 20.53 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- JARDIANCE® (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Adverse Drug Reactions (ADRs) |
20.53 | — |
| SECONDARY Change From Baseline in HbA1c (%) at the Last Observation During the Observation Period |
-0.36 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period |
-8.4 | — |
Summary
Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
Eligibility Criteria
Inclusion criteria
Male and female elderly patients (age 65 and over) with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment and start taking JARDIANCE® Tablets within 3 months after launch in Japan
Exclusion criteria
None
Data sourced from ClinicalTrials.gov (NCT02367131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.