UMIN-CTR Clinical Trial

Basic information
Public title	The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus
Acronym	The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus
Scientific Title	The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus
Scientific Title:Acronym	The effect of switching basal insulin regimen to dulaglutide on efficacy and safety in Japanese patients with type 2 diabetes mellitus
Region	Japan

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

Objectives
Narrative objectives1	We investigete the change on efficacy and safety associated with a switch from basal insulin to dulaglutide in patients with type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of continuous glucose monitoring when switching from basal insulin to dulaglutide
Key secondary outcomes	HbA1c and body waight after 24 weeks,QOL wtih DTSQ,occurrence of hypoglycemia

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We measure continuous glucose monitoring when switching basal insulin to dulaglutide. We measure the QOL of DTSQ at baseline of therapy with basal insulin and at after 24 weeks of therapy with dulaglutide.
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	The inclusion criteria were age => 20 years, diagnosis of type 2 diabetes, treatment with basal insulin for at least 24 weeks before entry into this study, and less than 1.0% HbAic change during the 24 weeks before entry into this study
Key exclusion criteria	1,Type 1 diabetes mellitus 2,Any patient who could not understand the device of ATEOS and DTSQ questionnaire 3,Any other condition which the attending physician feels would interfere with trial participation
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mohiriho Okada
Organization	Japan Community Healthcare Organization Kanazawa Hospital
Division name	Department of Pharmacy
Zip code
Address	Ha-15 Oki-machi, Kanazawa City, Ishikawa, Japan
TEL	076-252-2200
Email	okada-knz@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mohiriho Okada
Organization	Japan Community Healthcare Organization Kanazawa Hospital
Division name	Department of Pharmacy
Zip code
Address	Ha-15 Oki-machi, Kanazawa City, Ishikawa, Japan
TEL	076-252-2200
Homepage URL
Email	okada-knz@umin.ac.jp

Sponsor
Institute	Japan Community Healthcare Organization Kanazawa Hospital
Institute
Department

Funding Source
Organization	Japan Community Healthcare Organization Kanazawa Hospital
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 10 Month 01 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	Completed
Date of protocol fixation	2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 09 Month 02 Day
Last modified on	2018 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027439

Research Plan
Registered date	File name
2017/09/05	ﾃﾞｭﾗｸﾞﾙﾁﾄﾞ研究計画書ver2正本.doc

Research case data specifications
Registered date	File name
2017/09/05	Dulaglutide仕様書.xlsx

Research case data
Registered date	File name
2017/09/05	Dulaglutideﾃﾞｰﾀ.xlsx

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