UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006082 |
|---|---|
| Receipt number | R000007199 |
| Scientific Title | A multicenter trial of alogliptin for the safety and efficacy on glycemic control in Japanese type 2 diabetic patients undergoing hemodialysis |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2012/03/09 18:41:43 |
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Basic information
Public title
A multicenter trial of alogliptin for the safety and efficacy on glycemic control in Japanese type 2 diabetic patients undergoing hemodialysis
Acronym
Alogliptin in type 2 diabetic patients undergoing hemodialysis
Scientific Title
A multicenter trial of alogliptin for the safety and efficacy on glycemic control in Japanese type 2 diabetic patients undergoing hemodialysis
Scientific Title:Acronym
Alogliptin in type 2 diabetic patients undergoing hemodialysis
Region
| Japan |
Condition
Condition
Type 2 diabetic patients undergoing hemodialysis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluatuion of safety and efficacy of alogliptin on glycemic control in type 2 diabetic patients undergoing hemodialysis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in QOL, plasma glucose, HbA1c and glycated alubmin levels(0, 4, 8, 12, 16, 20 and 24 weeks after starting of treatment)
Key secondary outcomes
C-peptide and glucagon levels(0 and 24 weeks after starting of treatment)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Observation span: 24 weeks
Intervention: Alogliptin (Nesina)
Dose: 6.25mg once daily
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients undergoing hemodialysis, treated with insulin
Key exclusion criteria
1) Type 1 diabetic patients
2) Patients with insulin dose equal to or greater than 15 unit per day
3) Patients with liver disease
4) Patients with cancer disease
5) Patients with inflammatory disease
6) patients considered as inadequate by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuko Uchigata |
Organization
Tokyo Women's Medical University
Division name
Third Department of Medicine
Zip code
Address
8-1 Kawadacho, Shinjyukuku, Tokyo
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoshi Yoshida |
Organization
Tokyo Women's Medical University
Division name
Third Department of Medicine
Zip code
Address
TEL
03-3353-8111
Homepage URL
yoshida@dmc.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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 | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 30 | Day |
Last modified on
| 2012 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007199
