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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028141
Receipt No. R000032196
Scientific Title Effect of canagliflozin on cardiac function and baroreflex sensitivity in type 2 diabetic patients
Date of disclosure of the study information 2017/07/08
Last modified on 2018/01/06

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Basic information
Public title Effect of canagliflozin on cardiac function and baroreflex sensitivity in type 2 diabetic patients
Acronym Jikei canagliflozin cardiac function and baroreflex sensitivity assessment study (J-CANDY study)
Scientific Title Effect of canagliflozin on cardiac function and baroreflex sensitivity in type 2 diabetic patients
Scientific Title:Acronym Jikei canagliflozin cardiac function and baroreflex sensitivity assessment study (J-CANDY study)
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the effect of canagliflozin on cardiac function in type 2 diabetic patients.
Basic objectives2 Others
Basic objectives -Others To elucidate the effect of canagliflozin on baroreflex sensitivity in type 2 diabetic patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changed amount and percent change from baseline of the following value are evaluated:

Cardiac function
Key secondary outcomes The changed amount and percent change from baseline of each value below are evaluated:

1, Baroreflex Sensitivity (BRS)
2 fasting plasma glucose / HbA1c
3, low density lipoprotein cholesterol /high density lipoprotein cholesterol /triglyceride
4, estimated glemerular filtration rate (eGFR)
5, uric acid
6, brain natriuretic peptide (BNP)
7, total plasminogen activator inhibitor 1
8, albumin-to-creatinine ratio
9, body mass index
10, systolic blood pressure /diastolic blood pressure
11, hand strength

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administer canagliflozin

Patients take canagliflozin 100 mg once a day orally after breakfast for 90 days.
Interventions/Control_2
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
35 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria ・ Type 2 diabetic patients who are at age of 35 years or older and younger than 75 years when giving their consent.
・ Patients who have not changed drugs within 3 months of start.
・ At the time of giving consent, type 2 diabetic patients whose HbA1c (NGS) is 7.0% or higher and below 10.5%
・ Patients who can give their consent in a written form.
・ History or high risk of cardiovascular disease defined on the basis of either:

1, Patients who are at age of 35 years or older and younger than 75 years who have the following history:
stroke; myocardial infarction (MI); hospital admission for unstable angina; chronic heart failure; coronary artery bypass graft (CABG); percutaneous coronary intervention (PCI; with or without stenting); peripheral revascularization (angioplasty or surgery); symptomatic with documented hemodynamically significant carotid or peripheral vascular disease; or amputation secondary to vascular disease.

2, Patients who are at age of 45 years or older and younger than 75 years with 2 or more of the following risk factors determined at the screening
visit: duration of type 2 diabetes of 10 years or more, systolic blood pressure is 140 mmHg or higher (average of 3 readings) recorded at the screening visit, while the subject is on at least one blood pressure-lowering treatment, current daily cigarette smoker (brinkmann index is 200 and higher), microalbuminuria or macroalbuminuria, or dyslipidemia (any one of high-density lipoprotein cholesterol is below 40 mg/dl, low-density lipoprotein cholesterol is 120 mg/dl or higher, and triglyceride is 150mg/dl or higher); carotid intima media thickness1.1mm or higher, plaque positive


Key exclusion criteria ・having arrhythmia
・having severe renal dysfunction (serum Cr is 2.5 mg/dl or higher)
・having severe liver dysfunction (3X the upper limit of normal)
・having severe infection, severe trauma, or pre and post operation
・having diabetic ketosis, diabetic coma, or insulin-dependent diabetes mellitus
・being pregnant
・having malignancy
・being unsuitable for participation in the trial for any reason, according to the investigators
・heavy drinker
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Matsutani
Organization The Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Email daisuke19870116@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Matsutani
Organization The Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email daisuke19870116@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization Selt funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tsuruoka kyoritsu hospital
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 鶴岡協立病院(山形県)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 08 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
2017 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 08 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 07 Month 07 Day
Last modified on
2018 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032196

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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