evaluation of aloGliptin`s eFficacy and saFety based on Renal function Study

evaluation of aloGliptin`s eFficacy and saFety based on Renal function Study - evaluation of aloGliptin`s eFficacy and saFety based on Renal function Study (eGFR Study)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000006196

Enrollment

20000

Registered

2011-08-22

Start date

2011-08-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Type 2 diabetes patients with HbA1c(JDS value)level at baseline 5.8% - 8.0% 2) Type 2 diabetes patients under dietary/exercise therapy

Exclusion criteria

Exclusion criteria: Patients meeting one of the following conditions will be excluded: 1) Severe ketosis, diabetic coma or precoma, Type 1 diabetes 2) Severe infectious disease, before or after surgery, and severe trauma 3) Past medical history of hypersensitivity to alogliptin 4) hospitalized patient 5) Pregnant, lactating, and possibly pregnant women and those planning to become pregnant 6) Under treatment with other DPP-4 inhibitors and/or GLP-1 analogues 7) Judged as ineligible by clinical investigators

Design outcomes

Primary

Measure	Time frame
efficacy (HbA1c, GA, plasma glucose level, dosage of Alogliptin`s, serum creatinine, eGFR) safity (amylase, lipase, AST, ALT,gamma-GPT, hypoglycemia)	—

Secondary

Measure	Time frame
CPR, IRI, blood pressure, TC, TG, HDL, LDL, body weight, protein in urine, albumin/ creatinine ratio, retinopathy, macroangiopathy, incidence of cancer , diet and exercise assessment, QOL assessment, dosage of concomitant drugs	—

Countries

Japan

Outcome results