UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of satisfaction, efficacy and safety after switching from daily GLP-1 receptor agonist to weekly dulaglutide in patients with type 2 diabetes -open label, randomized, parallel group controlled clinical study-
Title of the study (Brief title)	Study for satisfaction and efficacy of dulaglutide
Region	Japan

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

Objectives
Narrative objectives1	To assess patients satisfaction, efficacy and safety of weekly GLP-1 receptor agonist compared with daily GLP-1 receptor agonist
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	The score of Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Key secondary outcomes	1)The score of Diabetes Therapy Related Quality of life (DTR-QOL) 2)Plasma glucose and HbA1c 3)Body weight and body mass index (BMI) 4)Blood test 5)The assessment of safety: frequency of hypoglycemia, digestive symptom, and so on

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 GLP-1 receptor agonist
Interventions/Control_2	Switching from daily GLP-1 receptor agonist to dulaglutide
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	1)Patients who were 20-year-old or older at the time of obtaining informed consent 2)Patients whose HbA1c level is more than 6.0% and less than 9.0% at the time of obtaining informed consent 3)Patients who were taking GLP-1 receptor agonist more than three months 4)Patients who are able to understand the study and willing to provide written informed consent
Key exclusion criteria	1)Patients who were taking weekly GLP-1 receptor agonist at the time of obtaining informed consent 2)Patients who have experienced severe diabetic ketosis, diabetic coma, or past history of pre-coma within six months 3)Patients with pregnancy or lactation 4)Patients who are taking systemic corticosteroid 5)Type 1 diabetes 6)Patients with severe infection, pre or post operation and severe trauma 7)Patients with severe liver dysfunction 8)Patients with severe renal dysfunction 9)Patients who are deemed to be unsuitable by the investigator
Target sample size	32

Research contact person
Name of lead principal investigator	Hideaki Miyoshi
Organization	Hokkaido University Graduate School
Division name	Division of Rheumatology, Endocrinology and Nephrology
Address	N-15, W-7, 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 Graduate School
Division name	Division of Rheumatology, Endocrinology and Nephrology
Address	N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Homepage URL
Email	hmiyoshi@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Graduate School
Institute
Department

Funding Source
Organization	Hokkaido University Graduate School
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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 08 Day
Anticipated trial start date	2016 Year 12 Month 06 Day
Last follow-up date	2017 Year 07 Month 11 Day
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 10 Month 24 Day
Last modified on	2018 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028119