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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: JARDIANCE®

• Registration Number: NCT02367131
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-20
• Study Start: 2015-02-24
• Primary Completion: 2016-09-27
• Study Completion: 2016-09-27
• Results First Submitted: 2017-09-11
• Results First Submitted QC: 2017-09-11
• Results First Posted: 2018-06-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 419

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JARDIANCE®	JARDIANCE®	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Adverse Drug Reactions (ADRs)	From first drug administration until 7 days after last drug adminstration, up to 52 weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (%) at the Last Observation During the Observation Period	Baseline and last observation on treatment, up to week 52.	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.
Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period	Baseline and last observation on treatment, up to week 52.	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.

Trial Locations

Locations (1)

NISND Center; 🇯🇵 Multiple Locations, Japan