Efficacy of empagliflozin to type 2 diabetic patients with ICD

JRCT ID: jRCTs031180120

Registered date:15/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type2 Diabetes
• Date of first enrollment: 19/04/2019
• Target sample size: 210
• Study type: Interventional

Intervention(s)

Empagliflozin group: Patients will be treated by empagliflozin 10mg once daily for 24 weeks.
Placebo group: Patients will be treated by placebo once daily for 24 weeks.

Outcome(s)

• Primary Outcome: frequency of lethal ventricular arrhythmia in implantable cardioverter-defibrillator

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Over 20 years
Patients with ICD
Type2 Diabetes

Exclude criteria

Liver disease with ALT, AST or ALP x3 ULN
Planned CV surgery, angioplasty, stroke and heart failure hospitalization in 6 month
eGFR <30 mL/min/1.73 m2 by MDRD equation
Nutritional disorders
Cancer
Nursing, pregnant, or child-bearing age women not using acceptable method of birth control or refusing pregnancy testing
Alcohol abuse

Related Information

• Primary Sponsor: Minamino Tohru
• Secondary Sponsor: Fujiki Shinya
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co ., Ltd.,Eli Lilly and Company,Nippon Boehringer Ingelheim Co ., Ltd.,Eli Lilly and Company