UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023834
Receipt No. R000027461
Scientific Title Impact of Dapagliflozin on Left ventricular hemodynamics and Exercise-induced Pulmonary hypertension evaluated by echocardiography in patients with type 2 diabetes; an open-label prospective randomized controlled trial
Date of disclosure of the study information 2016/08/30
Last modified on 2019/03/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Impact of Dapagliflozin on Left ventricular hemodynamics and Exercise-induced Pulmonary hypertension evaluated by echocardiography in patients with type 2 diabetes; an open-label prospective randomized controlled trial
Acronym Impact of Dapagliflozin on Left ventricular hemodynamics and Exercise-induced Pulmonary hypertension evaluated by echocardiography in patients with type 2 diabetes; an open-label prospective randomized controlled trial (IDOL-EPOC Study )
Scientific Title Impact of Dapagliflozin on Left ventricular hemodynamics and Exercise-induced Pulmonary hypertension evaluated by echocardiography in patients with type 2 diabetes; an open-label prospective randomized controlled trial
Scientific Title:Acronym Impact of Dapagliflozin on Left ventricular hemodynamics and Exercise-induced Pulmonary hypertension evaluated by echocardiography in patients with type 2 diabetes; an open-label prospective randomized controlled trial (IDOL-EPOC Study )
Region
Japan

Condition
Condition Type 2 DM complicated with high blood pressure
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the cardioprotective efficacy of dapagliflozin by comparing it with conventional antidiabetic agents in type 2 diabetic patients with hypertension
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The amount and percentage change in right ventricular systolic pressure (PASP) under exercise stress between the baseline and week 24
Key secondary outcomes 1. Measurement at each observation point, and the amount and percentage change in right ventricular systolic pressure (PASP) under exercise stress at the observation week 6

Measurement and amount and percentage change from the baseline to each observation point for the following parameters:
2. Left ventricular ejection fraction (EF; %) as contractility
3. Left ventricular diastolic performance [E/A, Dec-time, and tissue Doppler echocardiography (e')]
4. Left atrial pressure (E/e')
5. Right ventricular systolic pressure as right heart function
6. Exercise tolerance measured during cardiopulmonary exercise testing (minute ventilation volume, carbon dioxide excretion, oxygen intake at peak and anaerobic metabolic thresholds)
7. Blood pressure measured at home (early morning blood pressure measured immediately before starting the administration and 2-week mean of blood pressure measured before sleep)
8. CAVI value
9. Body weight, abdominal circumference, and body composition
10. Amount of physical activity
11. Vital signs and general blood/urine tests
12. Special blood/urine tests
13. Incidence of pulmonary hypertension (50 mmHg or higher at rest, or 60 mmHg or higher with load) before and after exercise load (within case comparison between time points during exercise load should be made using data obtained with the same load level)
14. Incidence of hypoglycemia
15. Low blood pressure incidence
16. Incidence of abnormal electrolyte levels (low Na and K)
17. Incidence of other adverse events


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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 Group A: Administer dapagliflozin
Dapagliflozin is administered in addition to oral hypoglycemic agents that are in-use at the time of registration to this study, and continue to the week 24.
Dapagliflozin is initiated at a dose of 5 mg, and the dose is not increased until the week 6 observation point.
Dapagliflozin shall be taken once a day after breakfast.
Interventions/Control_2 Group B: Conventional treatment (adding any OHAs excluding SGLT2)
Only one type of hypoglycemic agent, other than insulin, GLP-1 agonists, and SGLT2*, is administered at the following dose in addition to oral hypoglycemic agents that are in-use at the time of registration to this study (no dose increase of a drug that is already in-use is allowed), and continue the medications until the week 24. The drug to be added shall be used within the scope of insurance coverage.
(Intervention drug, initial dose)
Biguanides, 750-1500 mg/day
Thiazolidines, 15 mg/day
There are no restrictions set for other hypoglycemic agents

Although no restrictions are set on the frequency of doses given per day, the dosage will not be increased until the week 6 observation (the initial dose will be maintained).

*Also, combination drugs are not allowed.
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 Patients who meet all of the following criteria are included in this study.
1. Type 2 diabetic patients with HbA1c 7.0% to 9.0%
2. Patients who have been taking 1-3 different antidiabetic agents (oral hypoglycemic drugs) for at least12 weeks before consenting to study participation
3. Patients who were 20-year old or older, and younger than 80-year old at the time of consent
4. Patients with stage-I hypertension (early morning systolic blood pressure measured at home is 135 mmHg or higher and below 155 mmHg, or systolic blood pressure measured at office is 140 mmHg or higher and below 160 mmHg), stage-II hypertension (early morning systolic blood pressure measured at home is 155 mmHg or higher and below 175 mmHg, or systolic blood pressure measured at office is 160 mmHg or higher and below 180 mmHg), or an annually averaged systolic blood pressure measured at office is 140 mmHg or higher and below 160 mmHg, or currently on antihypertensive medication and with ischemic heart disease
5. Patients who can consent in writing
Key exclusion criteria Patients who fall into one or more of the following criteria are excluded from participating in the study.
1. Patients requiring a legally acceptable representative
2. Patients with type 1 diabetes
3. Patients who have received an SGLT2 inhibitor, subcutaneous injection of insulin, or subcutaneous injection of glucagon-like-peptide-1 agonist within 12 weeks before consenting to study participation
4. Patients with the stage-III hypertension (early morning systolic blood pressure measured at home is 175 mmHg or higher, or systolic blood pressure measured at office is 180 mmHg or higher)
5. Patients with chronic respiratory disease that needs medical treatment
6. Patients with pulmonary hypertension
7. Patients with severe renal failure (GFR is below 45 mL/min/1.73 m2)
8. Patients with an infectious disease or undergoing cancer treatment
9. Patients who have undergone surgery or catheter treatment within a year before consenting to study participation
10. Patients who are or may be pregnant
11. Patients who are drug addicted or alcohol dependent
12. Patients with NYHA III-IV heart failure
13. Patients considered inappropriate by their attending investigators
Target sample size 78

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Kayano
Organization Showa University School of Medicine
Division name Division of Cardiology, Department of Medicine,
Zip code
Address 1-5-8 Hatanaodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Email h-kayano@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
Address NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL 03-3295-1350
Homepage URL
Email takayama@soiken.com

Sponsor
Institute The Japan Society for Patient Reported Outcome
Institute
Department

Funding Source
Organization 1. AstraZeneca K.K.
2. Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2016 Year 08 Month 30 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
2016 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 09 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
2016 Year 08 Month 30 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027461

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.