UMIN-CTR Clinical Trial

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

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The Jikei University School of Medicine

Institute

Department

Personal name

Organization

Selt funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Tsuruoka kyoritsu hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

鶴岡協立病院（山形県）

Date of disclosure of the study information

2017

Year

07

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

07

Month

07

Day

Last modified on

2018

Year

01

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032196