Type 2 diabetes
Conditions
Interventions
One 50-mg tablet of Sitagliptin will be orally administered once daily for 12 weeks. Based on the therapeutic target, the dose can be increased to 100 mg.
Sponsors
Osaka University Graduate School of Medicine, Department of Cardiovascular Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes aged >20 years old who meet the following criteria and have fasting blood glucose (FPG) >126 mg/dL and HbA1c <8.4% (NGSP) or <8.0% (JDS) Patients who have not shown a sufficient response to any of the following treatments described in the package insert 1) Diet therapy and exercise therapy only 2) Use of a sulfonylurea drug in addition to diet therapy and exercise therapy Sulfonylurea drug (Amaryl, Euglucon, Glimicron and Daonil) Patients who meet the following exclusion criteria will be excluded. 3) Use of a thiazolidine drug in addition to diet therapy and exercise therapy Thiazolidine drug (Actos) 4) Use of a biguanide drug in addition to diet therapy and exercise therapy Biguanide drug (Melbin, Glycoran, Dibetos B and Metgluco) 5) Use of an alpha-glucosidase inhibitor in addition to diet therapy and exercise therapy alpha-glucosidase inhibitor (Basen, Seibule and Glucobay) 6) Use of an insulin product in addition to diet therapy and exercise therapy 2. Patients who give written informed consent to participate in the study on a voluntary basis after receiving and understanding a sufficient explanation of the study
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes 2. Patients with severe renal disorder (including hemodialysis) with a serum creatinine (Cr) level (mg/dL) >2.5 for males and >2.0 for females 3. Patients who have already received a sulfonylurea drug at a higher dose than the following dose: (Amaryl: 2 mg, Euglucon: 1.25 mg, and Glimicron: 40 mg), when it is clinically judged that the dose of the sulfonylurea cannot be decreased when sitagliptin is added. The criteria for a decrease in the dose of the sulfonylurea when sitagliptin is added are as follows: For patients who receive glimepiride (Amaryl) at a dose of >2 mg/day, the dose should be decreased to <2 mg/day. For patients who receive glibenclamide (Euglucon and Daonil) at a dose of >1.25 mg/day, the dose should be decreased to <1.25 mg/day. For patients who receive gliclazide (Glimicron) at a dose of >40 mg/day, the dose should be decreased to <40 mg/day. 4. Patients who have already taken Sitagliptin, Alogliptin, or Vildagliptin. 5. Patients who newly started taking a statin, fibrate, ezetimibe, or probucol within 1 month of the start of the study 6. Patients who are pregnant or may become pregnant 7. Patients receiving treatment for thyroid failure 8. Patients with severe hepatic dysfunction with AST and ALT >100 IU/L 9. Patients who have participated in another clinical study 10. Other patients who judged not to be eligible to participate in the study by their primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the following items will be evaluated at the beginning of administration and after the 12th week of administration. - Lipid oxidation markers (HODE, HETE) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Evaluation of following levels before and after the administration of Sitagliptin >Fasting Glucose >HbA1c(NGSP or JDS) >Triglyceride, total cholesterol, HDL-cholesterol, LDL-cholesterol >adiponectin, insulin, glucagon >free fatty acids(FFA) >apolipoproteinAI, AII, B, CII, CIII, E, apoB-48 >omentin, RemL-C, CystatinC, endotoxin - Incidence of side effects (hypoglycemia) | — |
Countries
Japan
Contacts
Public ContactDaisaku Masuda
Osaka University Graduate School of Medicine Department of Cardiovascular Medicine
Outcome results
None listed