UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011002 |
|---|---|
| Receipt number | 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 11:45:23 |
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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
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
Sponsor or person
Institute
First Department of Internal Medicine, Mie University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012876
