Type 2 diabetes
Conditions
Interventions
Teneligliptin
Sitagliptin
Sponsors
Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diabetes duration more than 1 year 2. Type 2 diabetes patients treated with dietand or exercise, and or SUs, and or BGs for more than 3 months 3. Diabetic nephropathy stage 2, 3 4. Age 20 - 80 5. Male and female 6. HbA1c 6.0% - 9.0% 7. No improvement of HbA1c over 0.5% in 3 months 8. Informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Patients to whom contraindications in the Package Insert apply 3. Patients whose participation in the study is judged to be difficult for reasons such as reduced ability to understand, unstable mental state, and alcoholism 4. The patients with type 1 diabetes mellitus and secondary diabetes 5. Patients treated with insulin and oral hypoglycemic agents except SUs and BGs for more than 3 months 6. Patients who have concomitant malignant tumors, or who have been treated for malignant tumors within the past 5 years 7. Foreigners, patients belonging to Kyoto University and/or Kyoto University Hospital, patients who is participating clinical trials 8. Other patients whose participation is judged to be inappropriate by the responsible physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c in 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in physical examination(weight, BMI, blood pressure) 2) Change in glycemic control(FPG, GA) 3) Change in Insulin secretion(CPR, IRI, CPI, HOMA-beta, HOMA-R) 4) Renal function amelioration (u-albumin, eGFR, s-creatinine, Cystatin C, u- L-FABP, u-Type-IV collagen) 5) Inflammatory and oxidative stress amelioration (hs-CRP, u-8-OHdG) 6) Vascular disorder marker amelioration (sVCAM-1) 7) Change in incretin related markers(DPP-4 activity, Active GLP-1, Active GIP, Glucagon) 8) Change in serum lipid profile(T-Chol,HDL,TG,LDL) 9) Achievement rate of HbA1c | — |
Countries
Japan
Contacts
Public ContactSyunsuke Yamane
Kyoto University Diabetes, Endocrinology and Nutrition
Outcome results
None listed