Japanese type 2 diabetes
Conditions
Interventions
The sitagliptin group is treated with sitagliptin in a range between 25mg (as a minimum dose) and 100mg (as a maximum dose) administrated once per day in the morning, for a period of 52 weeks.
The gli
Sponsors
Department of Diabetes and Clinical Nutrition, Graduate School of Medicine, Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The screening criteria of this study are as follows : 1.Japanese patients with type 2 diabetes 2.The glycemic inclusion criteria is less than HbA1c 8.0%,(They didn't exhibit decrease of HbA1c levels more than 1.0% in the last two months before the beginning of the study). 3.Age: Less than 80 years old. 4.No treatment with antidiabetic drugs for at least 1 months before the beginning of the study.
Exclusion criteria
Exclusion criteria: 1.Patients who could not sign informed consent for this study. 2.Patients with history of malignancy. 3.Patients with severe complications as follows: dysfunction of heart, lung, liver, kidney and pancreas and cerebral vessel disease as well as infections. 4.Patients with severe diabetic complications, such as bleeding diabetic retinopathy, diabetic nephropathy (eGFR<30), diabetic neuropathy, gangrene, ketosis, diabetic pre-coma and diabetic coma. 5.Patients during pregnancy or possible pregnant women. 6.Patients with type 2 diabetes using other antidiabetic drugs. 7.Patients with gastrointestinal symptoms such as diarrhea and vomiting. 8.Patients who are inadequate to entry this study. 9.Patients with severe frequent hypoglycemia and condition of hypoglycemia-unconsciousness. 10.Patients who are treated or will be treated with drugs which increase blood glucose such as steroids, interferon and tacrolimus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| insulinogenic index | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.HbA1c (%) (JDS value) 2.GA (%) 3.CPR/PG during OGTT 4.insulin/pro insulin rate 5.ISI composite=10000/(FPGxFIRIxmean OGTT PGxmean OGTT IRI)0.5 6.total GIP, total GLP-1 (pg/ml) 7.high-sensitive C-reactive protein (mg/) 8.total-Cho, LDL-Cho, HDL-Cho (mg/dl) 9.urinary albumin/creatinin (mg/g.Cr) 10.blood pressure (mmHg) 11.body weight (Kg) | — |
Countries
Japan
Contacts
Public ContactNorio Harada
Graduate School of Medicine, Kyoto University Department of Diabetes and Clinical Nutrition
Outcome results
None listed