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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008133
Receipt No. 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

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

Institute
Department

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
URL(English) https://upload.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


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