NIPH Clinical Trials Search

DIrect Effect of DPP-4 inhibitor on HbA1c levels and Renal Dysfunction

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Type 2 diabetes
Date of first enrollment	2014/09/01
Target sample size	120
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Teneligliptin Sitagliptin

Outcome(s)

Primary Outcome

Change in HbA1c in 6 months

Secondary Outcome

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

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	80years-old
Gender	Male and Female
Include criteria
Exclude 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