Study of the beneficial effect of Canagliflozin on nocturnal home BP in Japanese T2DM patients(SHIFT-J STUDY)

Not Applicable

• Conditions: Type 2 diabetes mellitus patients with hypertension

• Registration Number: JPRN-UMIN000023487
• Lead Sponsor: Jichi Medical University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

(Exclusion Criteria) (1) Taking SGLT2 inhibitors (2) Prescribed insulin (3) Taking diuretics (4) Prescribed GLP-1 receptor agonists (5) History of hypersensitivity due to SGLT2 inhibitors (6) History of cerebral infarction (7) Advanced renal dysfunction or end-stage renal failure and undergoing dialysis (8) Pregnant or possibility of pregnancy (9) Breastfeeding (10) Participating in another clinical study or trial (excluding observational studies) (11) Deemed ineligible for another reason by the study doctor (Exclusion Criteria for Enrollment) (1) Deemed difficult to continue in the study by the study doctor during observation due to home blood pressure measurement state (2) Severe adverse event observed during observation period (3) Deemed ineligible for another reason during the observation period by the study doctor

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
octurnal blood pressure changes from treatment period 0 weeks to treatment period 8 weeks

Secondary Outcome Measures

Name	Time	Method
Rates of change for the following items from treatment period 0 weeks to treatment period 8 weeks (1) Blood pressure (systolic blood pressure/diastolic blood pressure and pulse rate) -Home blood pressure parameters (early morning, before bedtime, and nocturnal) -Clinic blood pressure -Blood pressure variability (2) Metabolism-related factors -HbA1c -Body weight and BMI -Lipids and uric acid (3) NT-proBNP, ANP and urinary microalbumin Safety evaluation items -Adverse events and side effects -Clinical test values