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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023243
Receipt No. R000026431
Scientific Title Comparison of the efficacy of sitagliptin 25mg and teneligliptin 20mg in patient with type2 diabetes and chronic kidney disease.
Date of disclosure of the study information 2016/07/20
Last modified on 2016/07/20

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Basic information
Public title Comparison of the efficacy of sitagliptin 25mg and teneligliptin 20mg in patient with type2 diabetes and chronic kidney disease.
Acronym Comparison of the efficacy of sitagliptin 25mg and teneligliptin 20mg in patient with type2 diabetes and chronic kidney disease.
Scientific Title Comparison of the efficacy of sitagliptin 25mg and teneligliptin 20mg in patient with type2 diabetes and chronic kidney disease.
Scientific Title:Acronym Comparison of the efficacy of sitagliptin 25mg and teneligliptin 20mg in patient with type2 diabetes and chronic kidney disease.
Region
Japan

Condition
Condition type2 diabetes meliitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of the efficacy of sitagliptin 25mg and teneligliptin 20mg in patients with CKD and type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in blood glucose and HbA1c
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Distribution to a group as administration of sitagliptin 25mg for three months, followed by administration of teneligliptin 20mg for three months
Interventions/Control_2 Distribution to a group as administration of teneligliptin 20mg for three months, followed by administration of sitagliptin 25mg for three 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
100 years-old >
Gender Male and Female
Key inclusion criteria adult type 2 diabetes patients
Patients with renal function of eGFR 30~50ml/min/1.73m2, in oral teneligliptin 20mg
non insulin dependent state patients
patient's HbA1c are from 6 to 8 percent
Key exclusion criteria Patients of both drugs is contraindicated
Pregnancy, patients in nursing
Patients suffering from a severe disease requiring hospitalization
Patients with anemia (Hb <10g / dl)
Patients undergoing steroid therapy
Patients attending physician was found to be inappropriate for any reason
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name YASUO ZENIMARU
Organization University of Fukui Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 23-3 Shimoaitsuki Matsuoka Eiheiji-cho Yoshida-gun Fukui Japan
TEL 0776-61-3111
Email zenimaru@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name YASUO ZENIMARU
Organization University of Fukui Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 23-3 Shimoaitsuki Matsuoka Eiheiji-cho Yoshida-gun Fukui Japan
TEL 0776-61-3111
Homepage URL
Email zenimaru@u-fukui.ac.jp

Sponsor
Institute Department of Endocrinology and Metabolism University of Fukui Hospital
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 20 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
2016 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 02 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
2016 Year 07 Month 20 Day
Last modified on
2016 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026431

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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