UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006196 |
|---|---|
| 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 |
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Basic information
Public title
evaluation of aloGliptin`s eFficacy and saFety based on Renal function Study
Acronym
evaluation of aloGliptin`s eFficacy and saFety based on Renal function Study
(eGFR Study)
Scientific Title
evaluation of aloGliptin`s eFficacy and saFety based on Renal function Study
Scientific Title:Acronym
evaluation of aloGliptin`s eFficacy and saFety based on Renal function Study
(eGFR Study)
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of alogliptin on patients with type 2 diabetes will be investigated based on eGFR and dosage of alogliptin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
efficacy (HbA1c, GA, plasma glucose level, dosage of Alogliptin`s, serum creatinine, eGFR)
safity (amylase, lipase, AST, ALT,gamma-GPT, hypoglycemia)
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YUTAKA SEINO |
Organization
Kansai Electric Power Hospital
Division name
Division of Diabetes, Clinical Nutrition and Endocrinology
Zip code
Address
2-1-7 Fukushima, Fukushima-ku, Osaka-shi, Osaka-fu
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kansai Electric Power Hospital
Division name
Division of Diabetes, Clinical Nutrition and Endocrinology
Zip code
Address
2-1-7 Fukushima, Fukushima-ku, Osaka-shi, Osaka-fu
TEL
Homepage URL
prj-egfr@eps.co.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
evaluation of alogliptin`s efficacy and safety based on renal function
prospective study
Management information
Registered date
| 2011 | Year | 08 | Month | 18 | Day |
Last modified on
| 2012 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007265
