UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026630 |
|---|---|
| Receipt number | 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 08:59:44 |
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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
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
jojima@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo medical university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030579
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
