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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011678
Receipt No. R000013657
Scientific Title To Compare the renoprotective effect of sitagliptin and vildagliptin for patient with type 2 diabetic nephropathy
Date of disclosure of the study information 2013/09/07
Last modified on 2013/09/07

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Basic information
Public title To Compare the renoprotective effect of sitagliptin and vildagliptin for patient with type 2 diabetic nephropathy
Acronym To Compare the renoprotective effect of sitagliptin and vildagliptin for patient with type 2 diabetic nephropathy
Scientific Title To Compare the renoprotective effect of sitagliptin and vildagliptin for patient with type 2 diabetic nephropathy
Scientific Title:Acronym To Compare the renoprotective effect of sitagliptin and vildagliptin for patient with type 2 diabetic nephropathy
Region
Japan

Condition
Condition Diabetic nephropathy
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare the renoprotective effect of Sitagliptin and vildaagliptin in patients with type 2 diabetic nephropathy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Renal profile at 16 and 52 weeks after administration.
Key secondary outcomes Glucose profile at 16 and 52 weeks after administration.
Lipid profile at 16 and 52 weeks after administration.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is 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 sitagliptin
Interventions/Control_2 vildagliptin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who give informed consent
Key exclusion criteria Patients who has contraindication with sitagliptin
Patients who has contraindication with vildagliptin
Patients who judged as ineligible by clinical investigators
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Ito
Organization Machida Municipal Hospital
Division name Endocrine/diabetes
Zip code
Address 2-15-41 Asahimachi Machida-city Tokyo Japan
TEL 0427-22-2230
Email s.itou@machida-city-hp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Ito
Organization Machida Municipal Hospital
Division name Endocrine/diabetes
Zip code
Address 2-15-41 Asahimachi Machida-city Tokyo Japan
TEL 0427-22-2230
Homepage URL
Email s.itou@machida-city-hp.jp

Sponsor
Institute Machida Municipal Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Machida Municipal Hospital
Organization
Division
Category of Funding Organization Local Government
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
2013 Year 09 Month 07 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
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 23 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
2013 Year 09 Month 07 Day
Last modified on
2013 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013657


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