UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Comparison of SGLT-2 inhibitor, Luseogliflozin,versus GLP-1 Receptor Agonist,Dulaglutide, on Regression of Coronary Atherosclerosis with Type 2 Diabetes Mellitus who have Undergone Percutaneous Coronary Intervention: Open-label Randomized Parallel-group Trial
Title of the study (Brief title)	STILL-GLORY trial
Region	Japan

Condition
Condition	Type 2 diabetes who have undergone percutaneous coronary intervention
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of a GLP-1 receptor agonist, dulaglutide, with a SGLT-2 inhibitor, luseogliflozin on the progression of coronary atherosclerosis in patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in percent atheroma volume for 12 months during the treatment from baseline to study completion.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	patients recieving SGLT-2 inhibitor, luseogliflozin 2.5-5 mg/day, for 12 months
Interventions/Control_2	patients recieving GLP-1 receptor agonist, dulaglutide 0.75mg/week, for 12 months
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Type 2 diabetes who have undergone percutaneous Coronary intervention 2. Type 2 diabetes do not have poor glycemic control (HbA1c>7.0%), 3. Type 2 diabetes not recieving GLP-1 RA and SGLT-2 inhibitor before this trial, at least 3 months
Key exclusion criteria	Exclusion criteria were (1) type 1 diabetes, (2) severe complications of diabetes (3) hypersensitivity to the components of dulaglutide or luseogliflozin (4) severe liver, renal dysfunction (5) severe heart failure (NYHA 3,4) (6) pregnant or nursing women and those who might be pregnant (7) Familial Hypercholesterolemia: FH (8) Treatment with PCSK-9 inhibitor (9) any patients whom the investigators judgd to be inappropriate for this study.
Target sample size	200

Research contact person
Name of lead principal investigator	Yoshimasa Aso
Organization	Dokkyo medical university hospital
Division name	Endocrinology and Metabolism
Address	880,Kitakobayashi,Mibu,Shimotsugagun,Tochigi
TEL	0282-86-1111
Email	yaso@dokkyomed.ac.jp

Public contact
Name of contact person	Teruo Jojima
Organization	Dokkyo medical university hospital
Division name	Endocrinology and Metabolism
Address	880,Kitakobayashi,Mibu,Shimotsugagun,Tochigi
TEL	0282-86-1111
Homepage URL
Email	jojima@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo medical university hospital
Institute
Department

Funding Source
Organization	Taisho Toyama Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Dokkyo medical university hospital, Department of Cardiovascular Medicine Dokkyo medical university, Department of Public Health
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	2017 Year 04 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 02 Month 16 Day
Anticipated trial start date	2017 Year 05 Month 01 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	2017 Year 03 Month 21 Day
Last modified on	2018 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030579