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Study for the effect on blood pressure and heart rate fluctuation by switching from DPP-4 inhibitor to SGLT2 inhibitor Luseogliflozin in patients with type 2 diabetes. - multicenter, prospective, randomized, open-label, parallel group, comparison study -

Study for the effect on blood pressure and heart rate fluctuation by switching from DPP-4 inhibitor to SGLT2 inhibitor Luseogliflozin in patients with type 2 diabetes. - multicenter, prospective, randomized, open-label, parallel group, comparison study - - Luseogliflozin ABPM study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031451
Enrollment
60
Registered
2018-02-28
Start date
2018-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

Switching from DPP4 inhibitor to Luseogliflozin Continuing of DPP4 inhibitor

Sponsors

Hokkaido University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Changes in average of systolic blood pressure during the night-time section

Secondary

MeasureTime frame
Changes in average of diastolic blood pressure during the night-time section Changes in average of systolic and diastolic blood pressure during 24 hr 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

Countries

Japan

Contacts

Public ContactKyu Yong Cho

Hokkaido University Hospital Department of Medicine II/Clinical Research and Medical Innovation Center

kyuyong-cho@med.hokudai.ac.jp011-706-5915

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026