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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010905
Receipt No. 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

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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
Email

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
Email tetsuri218@yahoo.co.jp

Sponsor
Institute Minamisenju hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012761

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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