UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010905 |
|---|---|
| Receipt number | R000012761 |
| Scientific Title | Randomized crossover clinical trial comparing the effects of alogliptin and linagliptin on glycemic metabolism in hemodialysis patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2013/06/10 |
| Last modified on | 2014/01/25 18:49:26 |
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Basic information
Public title
Randomized crossover clinical trial comparing the effects of alogliptin and linagliptin on glycemic metabolism in hemodialysis patients with type 2 diabetes mellitus
Acronym
Comparison of alogliptin and linagliptin in hemodialysis patients with type 2 diabetes mellitus
Scientific Title
Randomized crossover clinical trial comparing the effects of alogliptin and linagliptin on glycemic metabolism in hemodialysis patients with type 2 diabetes mellitus
Scientific Title:Acronym
Comparison of alogliptin and linagliptin in hemodialysis patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
hemodialysis patients with type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of alogliptin and linagliptin on glycemic control and safety by crossover method
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
glycoalbumin and Hemoglobin A1c
Key secondary outcomes
plasma glucose, C-peptide, LDL cholesterol, adverse event
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of alogliptin 6.25mg in the first 3 months followed by the administration of linagliptin 5mg for 3 months
Interventions/Control_2
Administration of linagliptin 5mg in the first 3 months followed by the administration of alogliptin 6.25mg for 3 months
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
Hemodialysis patients of type 2 diabetes mellitus treated with DPP-4 inhibitors
Key exclusion criteria
1)Patients who has a history of hypersensitivity
2)Pregnant or possibly pregnant women and women on lactation
3)Ineligible patients according to the investigator's judgment
4)The patients who do not agree with this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ogawa Tetsuya |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Internal medicine
Zip code
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo, 116-8567, Japan
TEL
03-3810-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamashita Tetsuri |
Organization
Minamisenju hospital
Division name
Dialysis internal medicine
Zip code
Address
5-10-1 Minamisenju, Arakawa-ku, Tokyo 116-0003, Japan
TEL
03-3806-2232
Homepage URL
tetsuri218@yahoo.co.jp
Sponsor or person
Institute
Minamisenju hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
南千住病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 10 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 25 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 25 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 25 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 08 | Day |
Last modified on
| 2014 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012761
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
