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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024502
Receipt No. 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 2019/10/28

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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
Email 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
Email cardiostudy@ml.cc.saga-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Saga University
Institute
Department

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
Email 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
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 117
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
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
2019 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028197

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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