UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008133
Receipt number R000009573
Scientific Title Evaluation of efficacy and safety of Alogliptin in type 2 diabetic patients with chronic kidney disease
Date of disclosure of the study information 2012/06/12
Last modified on 2013/12/13 10:01:55

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Basic information

Public title

Evaluation of efficacy and safety of Alogliptin in type 2 diabetic patients with chronic kidney disease

Acronym

Evaluation of efficacy and safety of Alogliptin in type 2 diabetic patients with chronic kidney disease

Scientific Title

Evaluation of efficacy and safety of Alogliptin in type 2 diabetic patients with chronic kidney disease

Scientific Title:Acronym

Evaluation of efficacy and safety of Alogliptin in type 2 diabetic patients with chronic kidney disease

Region

Japan


Condition

Condition

Type 2 Diabetic Patients with chronic kidney Disease

Classification by specialty

Endocrinology and Metabolism Nephrology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will evaluate the efficacy and safety of Alogliptin in type 2 diabetic patients with chronic kidney disease. In this study, the target HbA1c (NGSP) would be 6.9%.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

HbA1c, at-any-time blood sugar level, blood pressure, albuminurina, proteinuria, eGFR at 0, 3, 6 and 12 months after starting of treatment

Key secondary outcomes

Body weight and side effects


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Add-on Alogliptin

Interventions/Control_2


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

1)Patients with chronic kidney disease 2)Type 2 Diabetic Patients 3)Patient who has not taken DPP-4 inhibitor
4)Patient who is competent to understand the aim of this study and agree on it

Key exclusion criteria

1)Type I and secondary diabetes
2)Severe infectious disease, before or after surgery, and severa trauma
3)Severe liver dysfunction (AST: 100 IU/l or higher)
4)Under treatment with an incretin preparation, such as other DPP-4 inhibitors, at the time of study initiation
5)Pregnant, lactating, and possibly pregnant women and those planning to become pregnant
6)Under treatment with therapeutic drugs not concomitantly administrable with incretin preparations, such as DPP-4 inhibitors, with regard to national health insurance
7)Past medical history of hypersensitivity to alogliptin
8)Judged as ineligible by clinical investigators

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiko Tomino

Organization

Juntendo University Faculty of Medicine

Division name

Department of Internal Medicine, Division of Nephrology

Zip code


Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-5802-1065

Email

yasu@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitoshi Suzuki

Organization

Juntendo University Faculty of Medicine

Division name

Department of Internal Medicine, Division of Nephrology

Zip code


Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

shitoshi@juntendo.ac.jp


Sponsor or person

Institute

Department of Internal Medicine, Division of Nephrology, Juntendo University Faculty of Medicine

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

A Clinic named 'Meguro Orthopaedics Surgery Internal Medicine'

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

順天堂大学病院(東京都)、目黒整形外科内科(東京都)


Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


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

2012 Year 04 Month 14 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 01 Day

Last follow-up date

2013 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 06 Month 10 Day

Last modified on

2013 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009573


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name