Unique ID issued by UMIN | UMIN000006196 |
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Receipt number | R000007265 |
Scientific Title | evaluation of aloGliptin`s eFficacy and saFety based on Renal function Study |
Date of disclosure of the study information | 2011/08/22 |
Last modified on | 2012/05/24 12:34:31 |
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)
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)
Japan |
Type 2 diabetes
Medicine in general | Endocrinology and Metabolism | Nephrology |
Others
NO
Efficacy and safety of alogliptin on patients with type 2 diabetes will be investigated based on eGFR and dosage of alogliptin
Safety,Efficacy
efficacy (HbA1c, GA, plasma glucose level, dosage of Alogliptin`s, serum creatinine, eGFR)
safity (amylase, lipase, AST, ALT,gamma-GPT, hypoglycemia)
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
Observational
Not applicable |
Not applicable |
Male and Female
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
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
20000
1st name | |
Middle name | |
Last name | YUTAKA SEINO |
Kansai Electric Power Hospital
Division of Diabetes, Clinical Nutrition and Endocrinology
2-1-7 Fukushima, Fukushima-ku, Osaka-shi, Osaka-fu
1st name | |
Middle name | |
Last name |
Kansai Electric Power Hospital
Division of Diabetes, Clinical Nutrition and Endocrinology
2-1-7 Fukushima, Fukushima-ku, Osaka-shi, Osaka-fu
prj-egfr@eps.co.jp
Kansai Electric Power Hospital
Self funding
Self funding
NO
2011 | Year | 08 | Month | 22 | Day |
Unpublished
Open public recruiting
2011 | Year | 08 | Month | 08 | Day |
2011 | Year | 08 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
evaluation of alogliptin`s efficacy and safety based on renal function
prospective study
2011 | Year | 08 | Month | 18 | Day |
2012 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007265
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