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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026630
Receipt No. R000030579
Scientific Title 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
Date of disclosure of the study information 2017/04/01
Last modified on 2018/03/12

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Basic information
Public title 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
Acronym STILL-GLORY trial
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshimasa Aso
Organization Dokkyo medical university hospital
Division name Endocrinology and Metabolism
Zip code
Address 880,Kitakobayashi,Mibu,Shimotsugagun,Tochigi
TEL 0282-86-1111
Email yaso@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruo Jojima
Organization Dokkyo medical university hospital
Division name Endocrinology and Metabolism
Zip code
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)

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
2017 Year 04 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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 16 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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