Type 2 diabetes mellitus patients with hypertension
Conditions
Interventions
The Hypoglycemic Treatment Enhancement Group received an increased dose of hypoglycemic agents (one agent) with diabetes treatment and antihypertensive treatment already being received or were additio
s course was observed over 8 weeks.
The Canagliflozin Addition Group was orally administered 100 mg of Canagliflozin (Canaglu(R) tablets), an SGLT2 inhibitor, once per day before or after breakfast in
s course was observed over 8 weeks.
Sponsors
Jichi Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Directly gave written consent to participate in this study (2) Aged 20 years or older at time of giving consent (3) Sex: Male or female (4) Treatment classification: Outpatient (Selection Criteria for Provisional Enrollment) (1) At the provisional enrollment, hypertension patients who meet all of the following requirements -Taking antihypertensive agents (at least past 3 months, patients with no history of changing antihypertensive medication) -As a rule, no changes in antihypertensive agent medication or dosage during the study -Clinic sitting systolic blood pressure of 130 - 159 mmHg and diastolic blood pressure of 80 - 99 mmHg (2) Type 2 diabetes mellitus patients with hemoglobin A1c (HbA1c)* of >=6.5% <10% when consent was obtained *Refers to HbA1c values measured at provisional enrollment or within 4 weeks before provisional enrollment. (3) Increased hypoglycemic dosage or additional administration of another hypoglycemic agent is being considered due to poor control (HbA1c below target value) (4) Taking one hypoglycemic agent (excluding combination drugs) (Selection Criteria for Enrollment) (1) During observation, mean systolic nocturnal home blood pressure (supine) (hereinafter: "nocturnal blood pressure") measured over 5 days before coming to hospital in treatment period week 0 was at least 115mmHg
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nocturnal blood pressure changes from treatment period 0 weeks to treatment period 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactSHIFT-J research group
Mebix, Inc. SHIFT-J research group
Outcome results
None listed