Luseogliflozin ABPM study

JRCT ID: jRCTs011180019

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 07/08/2018
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Switching from DPP4 inhibitor to Luseogliflozin versus continuing of DPP4 inhibitor

Outcome(s)

• Primary Outcome: Changes in average of systolic blood pressure during the night-time sectio

Secondary Outcome

Changes in average of diastolic blood pressure during the night-time section
Changes in average of systolic and diastolic blood pressure during 24hr
Changes in average of systolic and diastolic blood pressure during the day-time section
Blood pressure fluctuation in the night section relative to the day section
M-value
Trough of systolic and diastolic blood pressure for 1 hour before the next dose
Changes in heart rate
Changes in laboratory test value
Relationship between blood pressure reduction and weight loss

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1) HbA1c 6.0-9.0%.
2) Patients with type 2 diabetes who have been taking DPP-4 inhibitors (except weekly agents) for 4 weeks.
3) Patients with hypertension (>130/80 mmHg).
4) Written informed consent.

Exclude criteria

1) Patients with taking SGLT2 inhibitors.
2) Hypersensitivity to Luseogliflozin.
3) Uncontrolled diabetic retinopathy
4) Severe liver dysfunction, renal dysfunction, or heart failure
5) Pregnancy, nursing woman or possibly pregnant woman
6) Severe diabetic ketosis, diabetic coma
7) Severe infection, pre and post operation
, severe trauma
8) Deficiency of insulin secretion
9) BMI < 22kg/m2
10) eGFR < 30 ml/min
11) Patients with uncontrolled diet therapy.
12) Patients with irregular circadian rhythm.
13) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments

Related Information

• Primary Sponsor: Cho Kyuyong
• Source(s) of Monetary Support: Taisho Pharmaceutical Co., Ltd.
• Secondary ID(s): UMIN000031451