UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of dulaglutide in diabetic patients
Title of the study (Brief title)	The efficacy of dulaglutide in diabetic patients
Region	Japan

Condition
Condition	Type2 diabetic patients
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and the safety of dulaglutide in type2 diabetic patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	The primary end-point is plasma glucose, glycated albumin or HbA1c measurement twelve weeks after new, additional administration of dulaglutide and change from other GLP-1 receptor agonist in type 2 diabetic patients.
Key secondary outcomes	Other laboratory data and adverse events will be analyzed as well.

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	1) Fresh cases for GLP-1 receptor agonist: Patients with poor glycemic control after two months on dietary and exercise therapy 2) Supplementation case for GLP-1 receptor agonist: Patients with poor glycemic control on treatment with antidiabetic agents except GLP-1 receptor agonist 3) Cases whose treatment is changed from other GLP-1 receptor agonist 4) The criteria of poor glycemic control: HbA1c level exceeding 7.0% and/or glycated albumin level exceeding 21.0%
Key exclusion criteria	Patients having infectious diseases, thyroid disease, or malignant tumors. Patients being treated with steroids.
Target sample size	50

Research contact person
Name of lead principal investigator	Machiko Komatsu
Organization	Kawashima Hospital
Division name	Department of diabetes mellitus
Address	1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL	088-631-0110
Email	machikomatsu@r7.dion.ne.jp

Public contact
Name of contact person	Akiko Miyajima
Organization	Kawashima Hospital
Division name	The general affairs division
Address	1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL	088-631-0110
Homepage URL
Email	a.miyajima@khg.or.jp

Sponsor
Institute	Kawashima Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

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	川島病院（徳島県）、川島透析クリニック（徳島県）、鴨島川島クリニック（徳島県）、鳴門川島クリニック（徳島県）、脇町川島クリニック（徳島県）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 11 Month 10 Day
Anticipated trial start date	2015 Year 12 Month 03 Day
Last follow-up date	2020 Year 11 Month 30 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	Study design: case series study Recruitment of target people: All patients who consulted our facilities in from December 2015 through December 2018 and meet the inclusion/exclusion criteria Parameters: plasma glucose, glycated albumin or HbA1c measurement

Management information
Registered date	2015 Year 11 Month 28 Day
Last modified on	2017 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023064