UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011678
Receipt number 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 13:38:47

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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.


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



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 or person

Institute

Machida Municipal Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013657


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name