UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036531 |
|---|---|
| Receipt number | R000041616 |
| Scientific Title | Survey on postprandial hyperglycemia in patients with type 2 diabetes |
| Date of disclosure of the study information | 2019/04/19 |
| Last modified on | 2019/11/06 14:50:05 |
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Basic information
Public title
Survey on postprandial hyperglycemia in patients with type 2 diabetes
Acronym
Survey on postprandial hyperglycemia in patients with type 2 diabetes
Scientific Title
Survey on postprandial hyperglycemia in patients with type 2 diabetes
Scientific Title:Acronym
Survey on postprandial hyperglycemia in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the Web questionnaire, we will clarify the current status of treatment in patients with type 2 diabetes, as well as the recognition of postprandial hyperglycemia, the expectations and needs for postprandial hyperglycemia treatment,
Basic objectives2
Others
Basic objectives -Others
Contributing to the optimization of future treatment policy as an aid for realizing "patient-centered medical treatment".
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recognition of postprandial hyperglycemia, expectations for treatment
Key secondary outcomes
Treatment of diabetes
Influence on daily life
Communication with medical staff
Recognition and treatment of postprandial hyperglycemia
Expectations for postprandial hyperglycemia treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes
Patients who regularly go to medical institutions for treatment of type 2 diabetes
Key exclusion criteria
No specific criteria
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Aruse |
Organization
Qlife CO.,LTD
Division name
Representative Director and CEO
Zip code
105-0001
Address
7th Floor, Sumitomo Shin-Toranomon Bldg., 4-3-9 Toranomon, Minato-ku, Tokyo
TEL
03-6860-5020
k-aruse@qlife.co.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Kitahara |
Organization
QLife Co., Ltd.
Division name
Medical Solution
Zip code
105-0001
Address
7th Floor, Sumitomo Shin-Toranomon Bldg., 4-3-9 Toranomon, Minato-ku, Tokyo
TEL
03-6860-5020
Homepage URL
y-kitahara@qlife.co.jp
Sponsor or person
Institute
Qlife CO.,LTD
Institute
Department
Personal name
Funding Source
Organization
KISSEI 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
Mebix
Address
1-11-44 Akasaka Intercity, Akasaka, Minato-ku, Tokyo
Tel
03-4362-4500
no-mori@mebix.co.jp
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
| 2019 | Year | 04 | Month | 19 | 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
877
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
| 2019 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special
Management information
Registered date
| 2019 | Year | 04 | Month | 16 | Day |
Last modified on
| 2019 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041616
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
