Type 2 diabetes
Conditions
Interventions
initiate sitagliptin at dose of 50mg/day under the treatment of sulfonylurea at the following recommended dose (glimepiride, 2mg/day or less
glibenclamide, 1.25mg/day or less
gliclazide, 40mg/day or less) reduce dose of sulfonylurea or discontinue treatment of sulfonylurea based on the decision by attending physician, whenever the HbA1c value decreases to the targeted
6.5% [JDS] or <
6.9% [international standard]) increase dose of sitagliptin to 100mg/day when the HbA1c value dose is greater than the targeted level after 3 months of treatment. increase dose of sulfonylurea
Sponsors
Kyoto University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) treated with sulfonylurea or combination of sulfonylurea and biguanides, thiazolidine or alpha-glycosidase inhibitors for more than 3 months and not treated with DPP-4 inhibitors. 2) HbA1c value is between 6.5 and 8.0% [JDS] or between 6.9 and 8.4% [international standard]). 3) outpatients over 20 years old and under 80 regardless of sex. 4) obtained written informed consent and able to start intervention within 2 months.
Exclusion criteria
Exclusion criteria: 1) severe ketosis, diabetic coma or precoma 2) moderate renal dysfunction (male, serum creatinine &#8805;1.5 mg/dL; female, serum creatinine &#8805;1.3 mg/dL ) 3) severe infection , pre- or post-operation, or severe traumatic injury 4) pregnancy, child bearing potential, or nursing 5) history of hypersensitivity to sitagliptin. 6) inadequate due to other reasons by attending physician's judgments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c value | — |
Secondary
| Measure | Time frame |
|---|---|
| A) changes in value of the following datas from baseline to 12 months after treatment; fasting plasma glucose, total cholesterol, triglyceride, high density lipoprotein cholesterol, calculated low density lipoprotein cholesterol, body weight, C-peptide in the blood, proinsulin/insulin ratio, glucagon in the blood, leptin in the blood, and HOMA-beta, B) change in the dosage of sulfonylurea, C) occurrence of hypoglycemic attack, d) occurrence of adverse event. | — |
Countries
Japan
Contacts
Public ContactDepartment of EBM Research
Kyoto University Hospital iACT
Outcome results
None listed