UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044425