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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Jardiance

• Registration Number: NCT02489942
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-21
• Study Start: 2015-06-12
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-03
• Primary Completion: 2020-11-11
• Study Completion: 2020-12-04
• Status Verified: 2021-12
• Results First Submitted: 2021-12-02
• Results First Submitted QC: 2021-12-02
• Last Update Submitted: 2021-12-02
• Results First Posted: 2022-02-04
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8145

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	Patients with T2DM to receive Jardiance tablets 10 mg, 25 mg

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Drug Reactions (ADRs)	From first drug administration until 7 days after last drug administration, up to 247 weeks.	Number of patients with adverse drug reactions.

Secondary Outcome Measures

Name	Time	Method
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 haemoglobin A1c (HbA1c) at the last observation during the 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.	Change from baseline in fasting plasma glucose (FPG) at the last- observation during observation period.