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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036531
Receipt No. 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 2019/08/26

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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
Email 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
Email y-kitahara@qlife.co.jp

Sponsor
Institute Qlife CO.,LTD
Institute
Department

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
Email 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 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 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 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041616

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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