useogliflozin ABPM study

Phase 4

• Conditions: Type 2 diabetes mellitus

• Registration Number: JPRN-jRCTs011180019
• Lead Sponsor: Cho Kyuyong

Brief Summary

In type 2 diabetic patients with hypertension, switching from the DPP-4 inhibitor to the SGLT2 inhibitor luseogliflozin resulted in a decrease in systolic blood pressure and pulse rate in nighttime and the improvement in blood pressure circarian rhythm. It was suggested that these improvements may be involved in reducing cardiovascular events caused by SGLT2 inhibitors.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-19
• Study Completion: 2020-07-06
• Results First Posted: 2021-10-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 68

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in average of systolic blood pressure during the night-time sectio

Secondary Outcome Measures

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