UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of satisfaction and adherence among once-daily, twice-daily, and once-weekly DPP-4 inhibitors in type 2 diabetic patients
Title of the study (Brief title)	Comparison of satisfaction and adherence among once-daily, twice-daily, and once-weekly DPP-4 inhibitors in type 2 diabetic patients
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare patients' satisfaction and adherence among once-daily, twice-daily, and once-weekly DPP-4 inhibitors
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patients' satisfaction
Key secondary outcomes	Adherence Blood glucose

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treated with trelagliptin (once weekly) in period 1, teneligliptin (once daily) in period 2, and vildagliptin (twice daily) in period 3.
Interventions/Control_2	Treated with trelagliptin (once weekly) in period 1, vildagliptin (twice daily) in period 2, and teneligliptin (once daily) in period 3.
Interventions/Control_3	Treated with teneligliptin (once daily) in period 1, trelagliptin (once weekly) in period 2, and vildagliptin (twice daily) in period 3.
Interventions/Control_4	Treated with teneligliptin (once daily) in period 1, vildagliptin (twice daily) in period 2, and trelagliptin (once weekly) in period 3.
Interventions/Control_5	Treated with vildagliptin (twice daily) in period 1, teneligliptin (once daily) in period 2, and trelagliptin (once weekly) in period 3.
Interventions/Control_6	Treated with vildagliptin (twice daily) in period 1, trelagliptin (once weekly) in period 2, and teneligliptin (once daily) in period 3.
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	Type 2 diabetic patients treated with alogliptin
Key exclusion criteria	- Patients with severe hepatic, renal, and/or cardiac disease - Patients with hypersentitivity to the agents used in the current study - Patients who are pregnant, breast-feeding or may become pregnant - Patients who are judged by the investigator to be inappropriate for this study for any other reason.
Target sample size	180

Research contact person
Name of lead principal investigator	Toshihiko Shiraiwa
Organization	Shiraiwa Medical Clinic
Division name	Shiraiwa Medical Clinic
Address	4-10-24 Hozenji, Kashiwara, Osaka 582-0005, Japan
TEL	072-971-1221
Email	shiraiwa@endmet.med.osaka-u.ac.jp

Public contact
Name of contact person	Toshihiko Shiraiwa
Organization	Shiraiwa Medical Clinic
Division name	Shiraiwa Medical Clinic
Address	4-10-24 Hozenji, Kashiwara, Osaka 582-0005, Japan
TEL	072-971-1221
Homepage URL
Email	shiraiwa@endmet.med.osaka-u.ac.jp

Sponsor
Institute	Shiraiwa Medical Clinic
Institute
Department

Funding Source
Organization	Shiraiwa Medical Clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Smile Pharmacy
Name of secondary funｄer(s)

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	2015 Year 07 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 07 Month 04 Day
Anticipated trial start date	2015 Year 07 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 02 Day
Last modified on	2016 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021047