UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011386 |
|---|---|
| Receipt number | R000013336 |
| Scientific Title | Use of a New and Innovative Therapy for diabetes : Evaluation study |
| Date of disclosure of the study information | 2013/08/06 |
| Last modified on | 2015/08/07 15:43:15 |
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Basic information
Public title
Use of a New and Innovative Therapy for diabetes : Evaluation study
Acronym
UNITE Study
Scientific Title
Use of a New and Innovative Therapy for diabetes : Evaluation study
Scientific Title:Acronym
UNITE Study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate in the usual care setting the efficacy and safety of new diabetes drugs with a novel mechanism of action, including incretin-related drugs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Efficacy
Change in HbA1c and body weight.
Differential analysis by patients characteristics or concomitant drug.
2 Safety
Adverse events and those rates of occurrence
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
1.Diagnosis of type 2 diabetes
2.Age => 20 years
3.Receiving oral diabetes drugs with a novel mechanism of action (including incretin-related drugs) under usual care
4.Receiving ongoing diet/exercise therapy.
Key exclusion criteria
1.Current use of an insulin preparation
2.Diagnosis of type 1 diabetes
3.Current treatment with an investigational drug
4.Women who are pregnant, breastfeeding, or who hope to become pregnant
5.Patients whose participation is deemed inappropriate at the discretion of the attending physician.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seisuke Koumoto |
Organization
Japan Association for Diabetes Education and Care
Division name
Academic committee
Zip code
Address
2-2-4 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-3514-1721
koumoto@nittokyo.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Shihara |
Organization
Japan Association for Diabetes Education and Care
Division name
secretariat
Zip code
Address
2-2-4 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-3514-1721
Homepage URL
http://www.nittokyo.or.jp/about/research/report/detail.php?t=1&p=2
shihara@nittokyo.or.jp
Sponsor or person
Institute
Japan Association for Diabetes Education and Care
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
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 | 08 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A survey of commercially available drugs
performed by physicians on a voluntary basis
Management information
Registered date
| 2013 | Year | 08 | Month | 06 | Day |
Last modified on
| 2015 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013336
