Type 2 diabetes
Conditions
Interventions
Sitagliptin
Mitiglinide
Sponsors
Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Science,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) men and women with type 2 diabetes (aged >20); (2) modelately controlled diabetes with the change of HbA1c <3% within 12 weeks before screening; (3) insulin dosage of less than 60 units/24 h.
Exclusion criteria
Exclusion criteria: (1) had hypersensitivity or a contraindication to mitiglinide or sitagliptin; (2) had a history of type 1 diabetes or a history of ketoacidosis; (3) experienced repeated episodes of unexplained hypoglycaemia as defined by FPG or without the symptoms of hypoglycaemia or <60 mg/dl with symptoms of hypoglycaemia; (4) concomitantly suffering from infection and planning to have surgery; (5) treatment with a mitiglinide, and a sitagliptin within 12 weeks before screening; (6) concomitant corticosteroid therapy; (7) poorly controlled diabetes; (8) under dialysis and serum creatinine >2.5 mg/dl in men or >2.0 mg/dl in women; (9) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 2.5-fold the upper limit of normal; (10) poorly controlled hypertensions or systolic blood pressure>160 mmHg, or diastolic blood pressure>100 mmHg; (11) currently and/or previously suffering from heart failure; (12) severe retinopathy; (13) malignancy on active therapeutic regimen or without complete remission or cure; (14) pregnancy or breast feeding; (15) inadequacy to participate in the study, as assessed by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nadir FPG | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c lipid profile safety etc | — |
Countries
Japan
Outcome results
None listed