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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011002
Receipt No. R000012876
Scientific Title Clinical research of alogliptin in diabetic patients with metaboloc diseases
Date of disclosure of the study information 2013/06/20
Last modified on 2013/06/19

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Basic information
Public title Clinical research of alogliptin in diabetic patients with metaboloc diseases
Acronym Clinical research of alogliptin
Scientific Title Clinical research of alogliptin in diabetic patients with metaboloc diseases
Scientific Title:Acronym Clinical research of alogliptin
Region
Japan

Condition
Condition Diabetes mellitus
Classification by specialty
Medicine in general Gastroenterology Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to evaluate the clinical utility and safety of alogliptin in diabetic patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diabtes mellitus and related complications up to 48 weeks
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diabetes mellitus
Key exclusion criteria Active malignant diseases
Pregnancy
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuya Shiraki
Organization Mie University Hospital
Division name Gastroenterology
Zip code
Address 2-174, Edobashi, Tsu, Mie, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Mie University
Division name First Department of Internal Medicine
Zip code
Address
TEL 059-231-5015
Homepage URL
Email

Sponsor
Institute First Department of Internal Medicine, Mie University School of Medicine
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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 06 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 Preinitiation
Date of protocol fixation
2013 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2013 Year 06 Month 19 Day
Last modified on
2013 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012876

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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