UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039068 |
|---|---|
| Receipt number | R000044425 |
| Scientific Title | Sensory evaluation using mitiglinide / voglibose orally disintegrating tablets (OD tablets) and study of efficacy and safety |
| Date of disclosure of the study information | 2020/01/07 |
| Last modified on | 2021/01/07 13:11:12 |
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Basic information
Public title
Sensory evaluation using mitiglinide / voglibose orally disintegrating tablets (OD tablets) and study of efficacy and safety
Acronym
Sensory evaluation using mitiglinide / voglibose orally disintegrating tablets (OD tablets) and study of efficacy and safety
Scientific Title
Sensory evaluation using mitiglinide / voglibose orally disintegrating tablets (OD tablets) and study of efficacy and safety
Scientific Title:Acronym
Sensory evaluation using mitiglinide / voglibose orally disintegrating tablets (OD tablets) and study of efficacy and safety
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sensory evaluation of mitiglinide / voglibose combination OD tablets will be conducted in patients with type 2 diabetes who are scheduled to change treatment from mitiglinide / voglibose combination tablets to mitiglinide / voglibose combination OD tablets.
Basic objectives2
Others
Basic objectives -Others
Effectiveness before and after taking mitiglinide / voglibose combination OD tablets and safety after taking will be investigated.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensory evaluation questionnaires
Key secondary outcomes
HbA1c
Adverse events/Adverse reactions (hypoglycemic symptoms, etc.)
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
Outpatient who is going to Hotaruno Central Internal Medicine
Patients treated with mitiglinide / voglibose combination tablets 3 times a day for more than 2 months before changing to mitiglinide / voglibose combination OD tablets
Patients who wished to change treatment to take mitiglinide / voglibose OD tablets 3 times a day, before explaining about this clinical study
Patients who can answer questionnaires themselves
Patients with written consent
Patients over 20 years old at the time of obtaining informed consent
Key exclusion criteria
Patients who are judged inappropriate by the research doctor for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daigaku |
| Middle name | Daigaku Uchida |
| Last name | Uchida |
Organization
Hotaruno central clinic
Division name
Hotaruno central clinic
Zip code
292-0038
Address
3-30-3 Hotaruno, Kisarazu City, Chiba
TEL
0438-97-8855
uchida@hotarunonaika.com
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | Kaori Iwatake |
| Last name | Iwatake |
Organization
Satt Co., Ltd.
Division name
Clinical Study Group
Zip code
160-0022
Address
5th Floor, ACN Shinjuku Bldg., 2-12-8 Shinjuku, Shinjukuku, Tokyo
TEL
03-5312-5026
Homepage URL
kaori.iwatake@sa-tt.co.jp
Sponsor or person
Institute
KISSEI PHARMACEUTICAL 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
Hattori Clinic Ethics Review Committee
Address
1-15-18 Bessho, Hachioji-shi, Tokyo
Tel
0426-75-0032
kenji.kuwahara@sa-tt.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
| 2020 | Year | 01 | Month | 07 | 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
40
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 | 12 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 26 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 29 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 31 | Day |
Other
Other related information
Sensory evaluation of mitiglinide / voglibose combination OD tablets will be conducted in patients with type 2 diabetes who are scheduled to change treatment from mitiglinide / voglibose combination tablets to mitiglinide / voglibose combination OD tablets. And the effectiveness before and after taking mitiglinide / voglibose combination OD tablets and safety after taking will be investigated.
Management information
Registered date
| 2020 | Year | 01 | Month | 07 | Day |
Last modified on
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044425
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
