The renoprotective effect and safety of a DPP-4 inhibitor, Sitagliptin, in type 2 diabetic patients with a renal dysfunction when changed from other DPP-4 inhibitors

The renoprotective effect and safety of a DPP-4 inhibitor, Sitagliptin, in type 2 diabetic patients with a renal dysfunction when changed from other DPP-4 inhibitors - REAL Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016072

Enrollment

Registered

2014-12-29

Start date

2014-06-01

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

Depending on the degree of renal function, we intervene as following. Group A (eGFR 30-59 mL / min / 1.73m2): sitagliptin 25mg Group B (eGFR less than 30 mL / min / 1.73m2): sitagliptin 12.5mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with moderate or severe renal dysfunction (*1) (including end-stage renal failure patients) (*1 eGFR less than 60mL/min/1.73m2) 2) Patients with type 2 diabetes during treatment more than two months, in combination with DPP4 inhibitors other than sitagliptin (*2) or the DPP4 inhibitors inclusive other antidiabetics (*3) (*2 vildagliptin 50-100mg alogliptin 6.25-12.5mg linagliptin 5mg (*3 sulfonylureas, alfa-GIs, thiazolidines, insulins) 3) HbA1c of 6.0% or more, and less than 9.0% 4) Patient consent was obtained by document

Exclusion criteria

Exclusion criteria: 1) Patients with severe ketosis, or history of diabetic coma or precoma, within the past 6 months 2) Patients with severe infection, or before and after surgery, or severe trauma 3) Patients in pregnant or might be pregnant women or in nursing 4) Patients are prescribed biguanides or glinides or GLP-1 analogs 5) Patients with a history of hypersensitivity to DPP4 inhibitors 6) Patients who have been determined to be inappropriate for research participation by the attending physician

Design outcomes

Primary

Measure	Time frame
renal function (changes in eGFRcreat, eGFRcys, serum creatinie, and cystatin C) renoprotection (changes in urinary L-FABP, urinary albumin creatinine ratio, urinary type IV collagen, urinary 8- isoprostane, urinary beta 2 microgloburin, h-CRP)	—

Secondary

Measure	Time frame
glycemic control (changes in HbA1c, postprandial blood glucose level) lipid (changes in LDL-cholesterol, TG, HDL-cholesterol) changes in blood pressure, NT pro-BNP, ANP changes in active GLP-1, insulin levels, C- peptide changes in body weight changes in other laboratory values stratified analysis : prior medication, complications, blood glucose level, BMI, diabetes history, age safety assessment : incidence of adverse events, deterioration of renal function, and hypoglycemia	—

Measure

Time frame

glycemic control (changes in HbA1c, postprandial blood glucose level) lipid (changes in LDL-cholesterol, TG, HDL-cholesterol) changes in blood pressure, NT pro-BNP, ANP changes in active GLP-1, insulin levels, C- peptide changes in body weight changes in other laboratory values stratified analysis : prior medication, complications, blood glucose level, BMI, diabetes history, age safety assessment : incidence of adverse events, deterioration of renal function, and hypoglycemia

—

Countries

Japan

Contacts

Public ContactKoichi Kanozawa

Saitama Medical Center, Saitama Medical University Division of Nephrology and Hypertension

kanozawa@saitama-med.ac.jp049-228-3604

Outcome results

None listed

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