DIrect Effect of DPP-4 inhibitor on HbA1c levels and Renal Dysfunctio
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000012068
- Lead Sponsor
- Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University
- Brief Summary
HbA1c reduction of teneligliptin and sitagliptin in 24-weeks was -0.69% and -0.65%, respectively, with no significant difference between the two groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c in 6 months
- Secondary Outcome Measures
Name Time Method 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