Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim419 enrolled

Overview

Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.

Study Type

OBSERVATIONAL

Enrollment

419

Conditions

Diabetes Mellitus, Type 2

Interventions

JARDIANCE®DRUG

JARDIANCE®

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

NISND Center

Multiple Locations, Japan

Outcomes

Primary Outcomes

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.

Time frame: From first drug administration until 7 days after last drug adminstration, up to 52 weeks.

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline and last observation on treatment, up to week 52.

Data from ClinicalTrials.gov

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