type-2 diabetes mellitus
Conditions
Interventions
a group in which the dose of sitagliptin is to be increased from 50 mg to 100 mg (S group)
a group in which sitagliptin (50 mg) is to be switched to mitiglinide/voglibose fixed-dose combination table
Sponsors
University of Occupational and Environmental Health, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients treated with 50 mg of sitagliptin for at least 12 weeks, but who do not achieve the therapeutic goal HbA1c <6.5% (HbA1c upper limit: < 8.0, fluctuation range: within 0.5%). 2) Outpatients aged 20 or older. 3) Patients who have agreed in writing to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Patients treated with a sulfonylurea (SU), alfa-glycosidase inhibitor (alfa-GI) or insulin secretagogue (glinide). 2) Patients with diabetic ketoacidosis, diabetic coma/precoma or type-1 diabetes mellitus. 3) Patients with severe infection or serious trauma, or those operated recently or scheduled for surgery. 4) Patients with moderate or severer renal disorder (creatinine level 1.5 mg/dL (men) or 1.3 mg/dL (women)). 5) Patients with liver disorder (AST or ALT level 3 times the normal upper limit). 6) Women who are pregnant or suspected of being pregnant. 7) Women who are breastfeeding. 8) Patients with a history of hypersensitivity to an ingredient of the study drugs. 9) Other patients judged to be ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SD value | — |
Secondary
| Measure | Time frame |
|---|---|
| MAGE, mean glucose level over 24 hours, frequency of glucose levels > 180 mg/dL and < 70 mg/dL, Endo-PAT measurement, incidence of adverse reactions. | — |
Countries
Japan
Contacts
Public ContactArao Tadashi
Kyushu Rosai Hospital, Moji Medical Center Department of Internal Medicine , Division of Diabetes Mellitus, Hematology and Collagen Disease
Outcome results
None listed