UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of satisfaction and efficacy after switching from daily DPP-4 inhibitors to weekly trelagliptin in patients with type 2 diabetes -prospective observational study-
Title of the study (Brief title)	Study for the satisfaction and efficacy of trelagliptin
Region	Japan

Condition
Condition	type 2 diabetes mellitus
Classification by specialty	Medicine in general Endocrinology and Metabolism Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effectiveness of weekly DPP-4 inhibitor,on patients satisfaction and drug efficacy in patients with type 2 diabetes treating with daily DPP-4 inhibitors.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	DTSQ(Diabetes Treatment Satisfaction Questionnaire)
Key secondary outcomes	DTR-QOL(Diabetes Therapy Related Quality of life) HbA1c Plasma glucose Weight Frequency of hypoglycemia Stratified analysis(contributing factors, etc)using results of the questionnaire.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Keeping daily DPP-4 inhibitors
Interventions/Control_2	Switching from daily DPP-4 inhibitors to trelagliptin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with type 2 diabetes who have been taking standard dose of daily DPP-4 inhibitors(Sitagliptin 50mg/Vildagliptin 100mg/Alogliptin 25mg/Linagliptin 5mg/Teneligliptin 20mg/Anagliptin 200mg/Saxagliptin 5mg)for more than 12 weeks. 2)Age:20 to 80 years old 3)The number of medication is less than six other than DPP-4 inhibitor 4)Written informed consent
Key exclusion criteria	1) Patient with malignant tumor 2)Pregnancy, nursing woman or possibly pregnant woman 3)Patients with severe infection, pre or post operation, severe trauma 4)Patients who are taking kinds of steroid 5)Patients with severe liver dysfunction(AST,ALT>100U/L) 6) Type 1 diabetes mellitus 7) Patients with hypersensitivity to study drugs on this study 8)Patients who can not do diet and exercise therapy 9)Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size	48

Research contact person
Name of lead principal investigator	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Email	hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person	Hideaki Miyoshi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Homepage URL
Email	hmiyoshi@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hokkaido University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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	北海道大学病院（北海道）、青木内科クリニック(北海道)、栗原内科（北海道）、萬田記念病院（北海道）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 24 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 20 Day
Anticipated trial start date	2016 Year 06 Month 20 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	2016 Year 06 Month 23 Day
Last modified on	2016 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026338