Type 2 diabetes
Conditions
Interventions
Administer canagliflozin Patients take canagliflozin 100 mg once a day orally after breakfast for 90 days.
Sponsors
The Jikei University School of Medicine
Tsuruoka kyoritsu hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Type 2 diabetic patients who are at age of 35 years or older and younger than 75 years when giving their consent. ? Patients who have not changed drugs within 3 months of start. ? At the time of giving consent, type 2 diabetic patients whose HbA1c (NGS) is 7.0% or higher and below 10.5% ? Patients who can give their consent in a written form. ? History or high risk of cardiovascular disease defined on the basis of either: 1, Patients who are at age of 35 years or older and younger than 75 years who have the following history: stroke; myocardial infarction (MI); hospital admission for unstable angina; chronic heart failure; coronary artery bypass graft (CABG); percutaneous coronary intervention (PCI; with or without stenting); peripheral revascularization (angioplasty or surgery); symptomatic with documented hemodynamically significant carotid or peripheral vascular disease; or amputation secondary to vascular disease. 2, Patients who are at age of 45 years or older and younger than 75 years with 2 or more of the following risk factors determined at the screening visit: duration of type 2 diabetes of 10 years or more, systolic blood pressure is 140 mmHg or higher (average of 3 readings) recorded at the screening visit, while the subject is on at least one blood pressure-lowering treatment, current daily cigarette smoker (brinkmann index is 200 and higher), microalbuminuria or macroalbuminuria, or dyslipidemia (any one of high-density lipoprotein cholesterol is below 40 mg/dl, low-density lipoprotein cholesterol is 120 mg/dl or higher, and triglyceride is 150mg/dl or higher); carotid intima media thickness1.1mm or higher, plaque positive
Exclusion criteria
Exclusion criteria: ?having arrhythmia ?having severe renal dysfunction (serum Cr is 2.5 mg/dl or higher) ?having severe liver dysfunction (3X the upper limit of normal) ?having severe infection, severe trauma, or pre and post operation ?having diabetic ketosis, diabetic coma, or insulin-dependent diabetes mellitus ?being pregnant ?having malignancy ?being unsuitable for participation in the trial for any reason, according to the investigators ?heavy drinker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changed amount and percent change from baseline of the following value are evaluated: Cardiac function | — |
Secondary
| Measure | Time frame |
|---|---|
| The changed amount and percent change from baseline of each value below are evaluated: 1, Baroreflex Sensitivity (BRS) 2 fasting plasma glucose / HbA1c 3, low density lipoprotein cholesterol /high density lipoprotein cholesterol /triglyceride 4, estimated glemerular filtration rate (eGFR) 5, uric acid 6, brain natriuretic peptide (BNP) 7, total plasminogen activator inhibitor 1 8, albumin-to-creatinine ratio 9, body mass index 10, systolic blood pressure /diastolic blood pressure 11, hand strength | — |
Countries
Japan
Contacts
Public ContactDaisuke Matsutani
The Jikei University School of Medicine Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Outcome results
None listed