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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039068
Receipt No. 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 2020/07/09

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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
Email 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
Email kaori.iwatake@sa-tt.co.jp

Sponsor
Institute KISSEI PHARMACEUTICAL 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 Hattori Clinic Ethics Review Committee
Address 1-15-18 Bessho, Hachioji-shi, Tokyo
Tel 0426-75-0032
Email 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 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 No longer recruiting
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
2020 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044425

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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