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

Not Applicable

Recruiting

• Conditions: Type 2 diabetes

• Registration Number: JPRN-UMIN000006196
• Lead Sponsor: Kansai Electric Power Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-22
• Study Completion: 2015-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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