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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367131
• Other study ID #: 1245.98
• Status: Completed
• Start date: February 24, 2015
• Est. completion date: September 27, 2016

Study information

• Verified date: February 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: September 27, 2016
• Est. primary completion date: September 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• JARDIANCE®
JARDIANCE®

Locations

Country	Name	City	State
Japan	NISND Center	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.
Secondary	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.

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