type 2 diabetes mellitus
Conditions
Interventions
Study subjects shall be randomly assigned to one of 2 groups, namely, the Glubes combination tablet (MV) group or the glimepiride continuation group, and the clinical course shall be observed for 4 we
Sponsors
The Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients on low-dose SU (equivalent to glimepiride <=2 mg/day) meeting the following criteria. Eligible patients must meet all of the following criteria. 1)Outpatient 2)Fasting blood glucose less than 140 mg/dL and HbA1c not less than 6.9%(NGSP) 3)Willing to provide consent for participation in the study
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria will be excluded. 1)Having some contraindication to use of mitiglinide or voglibose 2)Excessive alcohol intake 3)Severely impaired liver or kidney function 4)Age <=75 years 5)Duration of diabetes >=10 years 6)Use of the study drug, glinide, or AGI within the previous 8 weeks 7)Ongoing treatment with a DPP-4 inhibitor, GLP-1 analog, or insulin 8)Any other condition that may potentially affect the efficacy evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of FMD (0 and 60 min) | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c, serum 1,5-AG, serum lipids, blood pressure, weight, safety parameters (hypoglycemia, liver function test abnormalities), insulin level in the meal tolerance test, blood glucose profile, serum MDA-LDL, serum nitrotyrosine, serum IL-6 | — |
Countries
Japan
Contacts
Public ContactTakashi Miwa
Tokyo Medical University The Department of Diabetes, Endocrinology and Metabolism
Outcome results
None listed