UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024502 |
|---|---|
| Receipt number | R000028197 |
| Scientific Title | Effect of Empagliflozin on Endothelial Function in Cardiovascular High Risk Diabetes Mellitus: Multi-Center Placebo-Controlled Double-Blind Randomized Trial |
| Date of disclosure of the study information | 2016/10/21 |
| Last modified on | 2022/12/26 16:21:29 |
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Basic information
Public title
Effect of Empagliflozin on Endothelial Function in Cardiovascular High Risk Diabetes Mellitus:
Multi-Center Placebo-Controlled Double-Blind Randomized Trial
Acronym
Effect of Empagliflozin on Endothelial Function in Cardiovascular High Risk Diabetes Mellitus:
Multi-Center Placebo-Controlled Double-Blind Randomized Trial (EMBLEM trial)
Scientific Title
Effect of Empagliflozin on Endothelial Function in Cardiovascular High Risk Diabetes Mellitus:
Multi-Center Placebo-Controlled Double-Blind Randomized Trial
Scientific Title:Acronym
Effect of Empagliflozin on Endothelial Function in Cardiovascular High Risk Diabetes Mellitus:
Multi-Center Placebo-Controlled Double-Blind Randomized Trial (EMBLEM trial)
Region
| Japan |
Condition
Condition
Type 2 diabetes with high risk of cardiovascular disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of empagliflozin, an SGLT2 inhibitor, on vascular endothelial function using reactive hyperemia index (RHI) measured by RH-PAT with high risk type 2 diabetic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in RHI from baseline to 24 weeks
Key secondary outcomes
Change and correlation with RHI change from baseline to 24 weeks in following items:
1) Double product (systolic blood pressure x heart rate)
2) baPWV (both sides)
3) Coefficient of variation of the R-R intervals in the ECG at rest and deep breathing (including the differences between the results at rest and deep breathing) and standard deviation of heartbeat intervals
4) LVEF, E/e' (echocardiogram)
5) Blood biomarkers
NT-proBNP, interleukin-8, high-sensitivity troponin I, receptor for advanced glycation end products (RAGE), angiopoietin-like protein 2 (ANGPTL2)
6) Renal function
Serum creatinine, eGFR, albumin excretion in urine corrected by creatinine, L-FABP in urine corrected by creatinine
7) Glycemic control
HbA1c, fasting blood glucose, glycoalbumin
8) Other laboratory tests
Blood pressure, pulse pressure, heart rate, body weight, BMI, total cholesterol, HDL-C, LDL-C, triglyceride, non-HDL-C, AST, ALT, gamma-GTP, uric acid, RBC, hemoglobin, hematocrit
9) Parameters measured by RH-PAT test other than RHI (eg. AI, HRV)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Empagliflozin 10 mg/day is administered orally before or after breakfast for 24 weeks while continuing the existing treatment for diabetes and other complicating diseases. During the treatment period, antidiabetic agents basically cannot be increased or added as much as possible, and diet therapy, exercise therapy, or treatment with antidiabetic agents other than SGLT2 inhibitors should be continued.
Interventions/Control_2
Placebo is administered orally before or after breakfast for 24 weeks while continuing the existing treatment for diabetes and other complicating diseases. During the treatment period, antidiabetic agents basically cannot be increased or added as much as possible, and diet therapy, exercise therapy, or treatment with antidiabetic agents other than SGLT2 inhibitors should be continued.
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) Age >=20 at consent
2) Type 2 diabetic patients with HbA1c (NGSP) >=6.0% and <10.0%, not changed the dosage of antidiabetic agents within a month before consent and considered possible to start or add/switch the study drug by investigator
3) Patients who received an explanation of the study and provided a written informed consent
Patients who meet at least one condition of the list 4) - 8) below
4) Chronic heart failure (NYHA class I-III, systolic or diastolic failure)
NYHA class remains unchanged in a month before consent, and the dose of heart failure drug (ACE inhibitor, ARB, beta blocker, diuretic etc.) also remains unchanged in a month before consent.
5) History of coronary artery disease (myocardial infarction and angina etc.) or cerebral infarction
6) Previous coronary revascularization (percutaneous transluminal coronary angioplasty, irrespective of the use of stent, or coronary artery bypass grafting
7) Presence of coronary artery stenosis >=50% luminal narrowing depicted by angiography or multi-slice computed tomography
8) Diagnosis of arteriosclerosis obliterans according to Guidelines for management of peripheral arterial occlusive diseases (JCS 2015 revised)
Key exclusion criteria
1) Type 1 diabetes
2) History of diabetic ketoacidosis or diabetic coma within 6 months
3) With severe renal dysfunction (eGFR < 45 mL/min/1.73 m2 or undergoing dialysis)
4) With serious liver dysfunction (AST or ALT is 3 times higher than site reference value)
5) Heart failure patients whose NYHA class is IV
6) With pituitary gland dysfunction or adrenal gland dysfunction
7) Hypotension (systolic blood pressure < 90 mmHg)
8) History of ischemic heart disease, myocardial infarction, unstable angina, cerebrovascular disease, or transient ischemic attack within 3 months before consent
9) Patients who have undergone percutaneous transluminal coronary angioplasty or coronary artery bypass grafting within 3 months before consent
10) Patients received SGLT2 inhibitor within a month before consent
11) Pregnant, possibly pregnant, planning to be pregnant, or nursing women
12) History of hypersensitivity to empagliflozin
13) Considered not eligible for the study by investigator due to complicating malignancy or careful administration of empagliflozin
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Node |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2364
cardiostudy@ml.cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Node |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2364
Homepage URL
cardiostudy@ml.cc.saga-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Saga University
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Eli Lilly and Company
IRB Contact (For public release)
Organization
Institutional Review Board,Saga University Hospital
Address
5-1-1 Nabeshima, Saga
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-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
佐賀大学（佐賀県）、琉球大学（沖縄県）、広島大学（広島県）、東京医科大学（東京都）、北里大学（神奈川県）、獨協医科大学（栃木県）、産業医科大学（福岡県）、横浜市立大学市民総合医療センター（神奈川県）、福島県立医科大学（福島県）、陣内病院（熊本県）、大分大学（大分県）、金沢大学（石川県）、獨協医科大学埼玉医療センター（埼玉県）、浦添総合病院（沖縄県）、出水総合医療センター（鹿児島県）、大阪市立大学（大阪府）、天心堂へつぎ病院・診療所（大分県）、JR広島病院（広島県）、兵庫医科大学（兵庫県）、東京慈恵会医科大学（東京都）、福岡大学（福岡県）、ウェルライフクリニックたまき内科（沖縄県）、中部徳洲会病院（沖縄県）、小山イーストクリニック（栃木県）、慶應義塾大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
https://cardiab.biomedcentral.com/articles/10.1186/s12933-017-0532-8
Publication of results
Published
Result
URL related to results and publications
https://diabetesjournals.org/care/article/42/10/e159/30471/Effect-of-Empagliflozin-on-Endothelial-Fu
Number of participants that the trial has enrolled
117
Results
https://diabetesjournals.org/care/article/42/10/e159/30471/Effect-of-Empagliflozin-on-Endothelial-Function-in
Results date posted
| 2022 | Year | 12 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://diabetesjournals.org/care/article/42/10/e159/30471/Effect-of-Empagliflozin-on-Endothelial-Function-in
Participant flow
https://diabetesjournals.org/care/article/42/10/e159/30471/Effect-of-Empagliflozin-on-Endothelial-Function-in
Adverse events
https://diabetesjournals.org/care/article/42/10/e159/30471/Effect-of-Empagliflozin-on-Endothelial-Function-in
Outcome measures
https://diabetesjournals.org/care/article/42/10/e159/30471/Effect-of-Empagliflozin-on-Endothelial-Function-in
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 20 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028197
