UMIN-CTR Clinical Trial

Public title

Effort of canagliflozin on metabolic syndrome parameters and biomarkers of heart, kidney and vascular diseases in patients with type 2 diabetes mellitus.

Acronym

Effort of canagliflozin on metabolic syndrome parameters and biomarkers of heart, kidney and vascular diseases in patients with type 2 diabetes mellitus.

Scientific Title

Effort of canagliflozin on metabolic syndrome parameters and biomarkers of heart, kidney and vascular diseases in patients with type 2 diabetes mellitus.

Scientific Title:Acronym

Effort of canagliflozin on metabolic syndrome parameters and biomarkers of heart, kidney and vascular diseases in patients with type 2 diabetes mellitus.

Region

Japan

Condition

type 2 diabetes mellitus

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We prospectively investigated efforts of canagliflozin on metabolic syndrome parameters and biomarkers of heart, kidney, and vascular diseases in patients with type 2 diabetes mellitus.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1) HbA1c, fasting blood glucose, HOMA-R and HOMA-beta
2) Body weight, adiponectin, triglyceride, remnant-like particle cholesterol and apoB-48
3) BNP and troponin
4) Cystatin C, albuminuria, L-FABP and NGAL
5) High-sensitivity CRP
6) Symptoms and laboratory test values

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) HbA1c >=6.5% and <10%, and a fasting plasma glucose (FPG) of <=270 mg/dL (HbA1c >=7.0% in case of having sulfonylureas).
2) BMI >=25kg/m2.
3) Patients receiving sulphonylureas, thiazolidinediones, biguanides and/or DPP4 inhibitors more than 8 weeks
4) Patients with blood pressure >=130/80 mmHg (systolic/diastolic).
5) Patients who have given written informed consent atenrollment.

Key exclusion criteria

1) Patients with allergy for canagliflozin.
2) Patients with severe ketosis, diabetic coma, diabetic precoma, or type 1 diabetes mellitus.
3) Patients with severe renal dysfunction (eGFR<30) including the patient who needs haemodialysis or peritoneal dialysis.
4) Patients with severe infection disease or serious trauma.
5) Patient with the history of an urinary tract infection or genital infection.
6) Pregnant women and women suspected of being pregnant.
7) Women during lactation.
8) Patient who had myocardial infarction or cerebral infarction within 3 months before the informed consent.
9) Patients with insulin therapy.
10) Patients whose doctor judges to unfit for this study.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Junichi Ishii

Organization

Fujita Health University School of Medicine

Division name

Department of Joint Research Laboratory of Clinical Medicine

Zip code

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake 470-1192, Japan.

TEL

81-0562-93-2312

Email

jishii@fujita-hu.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroyuki Naruse

Organization

Fujita Health University School of Medicine

Division name

Department of Joint Research Laboratory of Clinical Medicine

Zip code

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake 470-1192, Japan.

TEL

81-0562-93-2312

Homepage URL

Email

hnaruse@fujita-hu.ac.jp

Institute

Fujita Health University School of Medicine

Institute

Department

Personal name

Organization

Mitsubishi Tanabe Pharma Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2015

Year

07

Month

06

Day

URL releasing protocol

Publication of results

Published

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

2014

Year

10

Month

09

Day

Date of IRB

Anticipated trial start date

2014

Year

10

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Observational study

Registered date

2015

Year

07

Month

01

Day

Last modified on

2018

Year

05

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021023