Type 2 diabetes mellitus Type 2 diabetes mellitus
Conditions
Interventions
mitiglinide/voglibose fixed-dose combination (M/V) precedent group: After 5 days observation period, patients receive treatment with M/V (mitiglinide 10mg/voglibose 0.2 mg, three times a day) for 5 da
Sponsors
Okada Yosuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with type 2 diabetes (diagnostic criteria according to Japanese clinical practice guideline for Diabetes 2016) 2) Patients with 7.0% or more and less than 10.0% of HbA1c measured within 2 months before enrollment 3) Patients being treated with metformin (include combination therapy of DPP-4 inhibitor) 4) Patients hospitalized or scheduled to be hospitalized during the study period for the treatment of diabetes 5) Patients who are 20 years old or older to under 80 years old at the time of obtaining consent 6) Patients who agreed in writing about participation in the study
Exclusion criteria
Exclusion criteria: 1) Patients who are being treated with hypoglycemic agents (including insulin therapy) other than Metformin (include combination therapy of DPP-4 inhibitor) 2) Patients with fasting blood glucose 200 mg/dL or more measured within 2 weeks before enrollment 3) Patients with severe liver dysfunction (AST or ALT, over 100 IU / L measured within 2 weeks before enrollment) 4) Patients with severe renal dysfunction (eGFR, less than 30 mL/min/1.73 m^2 measured within 2 weeks before enrollment) 5) Patients with severe ketosis, diabetic coma or pre-coma, and insulin-dependent diabetes (such as juvenile-type diabetes, brittle-type diabetes, and type 1 diabetes) 6) Patients with severe infection, before and after surgery, severe injury 7) Patients with gastrointestinal disorders such as diarrhea and vomiting 8) Patients who are pregnant or may be pregnant 9) Patients with a history of hypersensitivity to components of mitiglinide/voglibose fixed-dose combination and glimepiride or sulfonamides 10) Others, patients judged to be unsuitable for this study by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) reactive hyperemia index: RHI 2) mean amplitude of glycemic excursions: MAGE | — |
Secondary
| Measure | Time frame |
|---|---|
| CGM Parameter: 1) Mean of Blood glucose 2) SD of Blood glucose 3) CV of Blood glucose 4) Estimated HbA1c (eA1c) 5) AUC or AOC of blood glucose response curve adverse events and adverse drug reactions | — |
Contacts
Public ContactKenichi Tanaka
Hospital of the University of Occupational and Environmental Health, Japan
Outcome results
None listed