The effect on the renal functions and blood pressure of DPP-4 Inhibitor for the type 2 diabetic patients .

The effect on the renal functions and blood pressure of DPP-4 Inhibitor for the type 2 diabetic patients . - Sitagliptin therapy for blood glucose ,BP,and renal function in type 2 diabetic patients.(STABAR)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005337

Enrollment

100

Registered

2011-03-29

Start date

2011-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Add-on Stagliptin (50mg ) for 12 months, after 3 months, the physician can increase the dose of Sitagliptin to 100mg or titlate the antidiabetic agent. In case of the patients with moderate renal impa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with type 2 diabetes (6.5%<=HbA1c<9.0%) who has suboptimal glycemic control by only with the diet and exercise therapy and or with anti-diabetic agents add-on with the diet and exercise therapy for more than 1 month treatments. 2)Patients with the age between 20-80 years old who agreed with the participation in this study with written consent.

Exclusion criteria

Exclusion criteria: 1)Patients with type 1 diabetes 2)History of severe ketosis, diabetic coma or precoma within 6 months 3)Patients with severe infections, before or after operation, or with serious trauma 4)Ptientswho are pregnant, breast-feeding and/or intention to become pregnant 5)Patients with the severe renal impairment 6)Patients receiving Alfa-glycosidase inhibitor, Glinide or Insulin 7)Patients receiving DPP-4 inhibitor other than Sitagliptin 8)Patients having allergies against DPP-4 inhibitor or alfa-Glycosidase inhibitor 9)Patients determined to be inappropriate for the study by physician based on the scientific grounds.

Design outcomes

Primary

Measure	Time frame
Change from baseline in HbA1c at Month 3.	—

Secondary

Measure	Time frame
1)Change for the following parameters between the baseline and the after 3, 6, 9 and 12 months.. 1.blood pressure at the doctor's office-visit 2.blood pressure at home in the early morning 3.urinary micro-albumin level (creatinin equivalent) 4.eGFR 5.cystatin C 6.HbA1c(except the 3 months later) 7.casual blood glucose level 8.lipid level (HDL-C,LDL-C,TG) 9.hs-CRP 10.body weight 2)Change for 24-hour blood pressure between the baseline and after 6 and 12 months 3)Safety	—

Measure

Time frame

1)Change for the following parameters between the baseline and the after 3, 6, 9 and 12 months.. 1.blood pressure at the doctor's office-visit 2.blood pressure at home in the early morning 3.urinary micro-albumin level (creatinin equivalent) 4.eGFR 5.cystatin C 6.HbA1c(except the 3 months later) 7.casual blood glucose level 8.lipid level (HDL-C,LDL-C,TG) 9.hs-CRP 10.body weight 2)Change for 24-hour blood pressure between the baseline and after 6 and 12 months 3)Safety

—

Countries

Japan

Contacts

Public ContactDaisuke Koya

Kanazawa Medical University Diadetes & Endocrinology

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026