Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 7.0 and 12.4 %) under medical treatment by dieting and exercise cure and/or drug treatment. 2)Over 20 years old and less than 80 years old 3)Sex unquestioned 4)Patients with no history of cardiovascular disease 5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization. 6)The patient who gives a written informed
Exclusion criteria
Exclusion criteria: 1)Type 1 diabetes 2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges) 3)A pregnant woman and/or a woman under breast-feeding 4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women) 5)Diabetic proliferative retinopathy 6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug 7)Cigarette smokers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in 24-hr glycemic variability using continuous glucose monitoring systems , Differences in 24-hr heart rate variability evaluated by power spectral analysis Differences in 24-hr mean heart rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour blood pressure variability Gastric emptying rate by an acetaminophen loading test Orthostatic hypotension by Schellong test Plasma levels of A- and B-type natriuretic peptide (ANP and BNP) Serum 1, 5 anhidroglucitol (1, 5-AG) Safety evaluation | — |
Countries
Japan
Contacts
Dokkyo Medical University Department of Endocrinology and Metabolism