UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018395 |
|---|---|
| Receipt number | R000021301 |
| Scientific Title | Prospective comparison of Luseogliflozin and alpha-glucosidase inhibitor on the management of diabetic patients with chronic heart failure and preserved left-ventricular ejection fraction |
| Date of disclosure of the study information | 2015/09/20 |
| Last modified on | 2020/01/27 15:31:24 |
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Basic information
Public title
Prospective comparison of Luseogliflozin and alpha-glucosidase inhibitor on the management of diabetic patients with chronic heart failure and preserved left-ventricular ejection fraction
Acronym
Prospective comparison of Luseogliflozin and alpha-glucosidase inhibitor on the management of diabetic patients with chronic heart failure and preserved left-ventricular ejection fraction
Scientific Title
Prospective comparison of Luseogliflozin and alpha-glucosidase inhibitor on the management of diabetic patients with chronic heart failure and preserved left-ventricular ejection fraction
Scientific Title:Acronym
Prospective comparison of Luseogliflozin and alpha-glucosidase inhibitor on the management of diabetic patients with chronic heart failure and preserved left-ventricular ejection fraction
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of luseogliflozin on LV load in type 2 diabetic patients with heart failure with preserved ejection fraction compared to an alpha-glucosidase inhibitor, voglibose.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in BNP at 12 weeks
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
SGLT2 inhibitor, luseogliflozin
5 mg once a day
Interventions/Control_2
alpha-glucosidase inhibitor, voglibose
0.3mg three times/day
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Type 2 diabetic patients with LV ejection fraction > 45% and a symptom of heart failure
2) Inadequately controlled type 2 diabetic patients who have received alimentary therapy, exercise therapy, a lifestyle modification program, and hypoglycemic medications
3) Age >40 years and <75 years
4) Patients from whom a written informed consent was obtained
Key exclusion criteria
1) BNP <35 pg/ml
2) Patients receiving alpha-glucosidase inhibitors, SGLT2 inhibitors, glinides, high-dose sulfonylurea
3) Patients with renal insufficiency (eGFR< 30 ml/min/1.73m2)
4) LVEF<45%
5) Patients with history of severe ketoacidosis, diabetic coma within six months
6) Patients with serious infection and severe trauma, and perioperative patients
7) Type 1 diabetes mellitus
8) Poorly controlled type2 diabetic patients (HbA1c > 9.0%)
9) Uncontrolled hypertensive patients (systolic blood pressure >160mmHg)
10) Patients with history of stroke, myocardial infarction and severe cardiovascular disease with hospitalization within six months
11) Pregnant women and breast-feeding women
12) Patients with allergy for test drugs
13) Patients who is not suitable to this study due to medical reasons
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ito |
Organization
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name
Cardiovascular Medicine
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
itomd@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Miyoshi |
Organization
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name
Cardiovascular Medicine
Zip code
700-8558
Address
2-5-1 Shikada-cho Kita-ku Okayama
TEL
086-235-7351
Homepage URL
miyoshit@cc.okayama-u.ac.jp
Sponsor or person
Institute
Cardiovascular Medicine
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Novartis
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Okayama University
Address
2-5-1 Shikada-cho Kita-ku Okayama
Tel
086-235-6503
mae6605@adm.okayama-u.ac.jp
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
| 2015 | Year | 09 | Month | 20 | 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 | 30 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 23 | Day |
Last modified on
| 2020 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021301
