UMIN-CTR Clinical Trial

Public title

Prevention of atherosclerosis by SGLT2 inhibitor; multicenter, randomized controlled study

Acronym

PROTECT

Scientific Title

Prevention of atherosclerosis by SGLT2 inhibitor; multicenter, randomized controlled study

Scientific Title:Acronym

PROTECT

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Cardiology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the safety and compare arteriosclerosis by intima media thickness (IMT), glucose and lipid metabolism, blood pressure, cardiovascular function among the ipragliflozin group, administrated SGLT-2 (ipragliflozin), and the control group, not administrated SGLT-2.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in mean IMT of common carotid artery from baseline to month 24

Key secondary outcomes

1) Change in mean IMT of carotid bulb and mean IMT of internal carotid artery from baseline to month 24
2) Change in max IMT of common carotid artery, max IMT of carotid bulb, and max IMT of internal carotid artery from baseline to month 24
3) Mean of mean IMT of common carotid artery, carotid bulb, and internal carotid artery, respectively and change in it from baseline to month 24
4) Mean of max IMT of common carotid artery, carotid bulb, and internal carotid artery, respectively and change in it from baseline to month 24
5) Values and change in following items of laboratory test from baseline to month 24
High sensitivity CRP, MDA-LDL, NT-proBNP, high molecular weight adiponectin
6) Values and change in following items of laboratory test from baseline to month 12 and 24
Blood pressure, body weight, BMI, waist circumference visceral fat and subcutaneous fat area (abdominal CT, month 24 only), HbA1c (NGSP), fasting blood glucose, serum lipid [TC, LDL-C (Direct method), HDL-C, TG, Non-HDL-C], AST, ALT, gamma-GTP, uric acid, serum creatinine, eGFR (adjusted value), excretion of urinary albumin (creatinin equivalent)
7) Values and change in following items of cardiovascular function test from baseline to month 24
Echocardiography (LAVI, %EF, LVMI, E/A, DT, E/e', IVCd), FMD, PWV, CAVI, AI

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of ipragliflozin 50 mg once a day pre or post breakfast. When it is insufficiently effective, it can be increased to 100 mg once a day. When it is insufficient effective inspite of increase the dose, it can be added and increased the dose of antidiabetic agents except for SGLT-2 inhibitor.

Interventions/Control_2

In principle, antidiabetic agents should not be added and incresed the dose and diet/exercise therapy and administration of antidiabetic agents except for SGLT-2 are continued during treatment period. However, if it is insufficiently effective, it can be added and increased the dose of antidiabetic agents except for SGLT-2 inhibitor.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Type 2 diabetes with HbA1c (NGSP) >=6.0% and <10.0% nevertheless diet/exercise therapy or diet/exercise therapy adding antidiabetic agents for >=3 months
2) >=20 of age at the time of informed consent acquisition and hospitalization or outpatient
3) The patient provided written informed consent to participate in the study

Key exclusion criteria

1) Type 1 diabetes
2) Has history of severe ketosis, diabetic coma, or precoma within 6 months
3) Has severe infection, serious trauma, or pre or post surgery (including carotid endarterectomy and stent implantation)
4) With severe renal dysfunction (eGRF <45 mL/min/1.73m² or patient undergoing artificial dialysis)
5) Has history of myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attacks within 3 months before initiation of the study
6) Heart failure patient whose NYHA functional classification is III or IV
7) Has history of administration of SGLT-2 within 1 month before initiation of the study
8) Pregnant, possibly pregnant, planned to become pregnant or nursing women
9) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragliflozin
10) Are considered not eligible for the study by the attending doctor due to other reasons

Target sample size

480

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

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

Institute

Department of Cardiovascular Medicine, Saga University

Institute

Department

Personal name

Organization

Astellas Pharma Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutionnal 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

YES

Study ID_1

jRCTs071180041

Org. issuing International ID_1

Japan Registry of Clinical Trials

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

佐賀大学（佐賀県）
獨協医科大学（栃木県）
徳島大学（徳島県）
鹿児島大学（鹿児島県）
自治医科大学（栃木県）
長崎大学（長崎県）
北里大学（神奈川県）
広島大学（広島県）
東京医科大学（東京都）
日本医科大学（東京都）
宮崎市郡医師会病院（宮崎県）
佐賀県医療センター好生館（佐賀県）
国際医療福祉大学病院（栃木県）
名古屋第一赤十字病院（愛知県）
防衛医科大学校（埼玉県）
JR広島病院（広島県）
名古屋第二赤十字病院（愛知県）
獨協医科大学埼玉医療センター（埼玉県）
済生会二日市病院（福岡県）
国保旭中央病院（千葉県）
伊万里有田共立病院（佐賀県）
大阪医科大学（大阪府）
医療法人社団旭和会　東京駅センタービルクリニック（東京都）
浦添総合病院（沖縄県）
陣内病院（熊本県）
公立陶生病院（愛知県）
春日井市民病院（愛知県）
福島県立医科大学附属病院（福島県）
名古屋大学（愛知県）
福岡大学病院（福岡県）
済生会福島病院（福島県）
済生会熊本病院（熊本県）
名古屋市立大学病院（愛知県）
大阪市立大学（大阪府）
横浜南共済病院（神奈川県）
産業医科大学（福岡県）
和歌山県立医科大学（和歌山県）
会津中央病院（福島県）
土井内科胃腸科医院（熊本県）
国立循環器病研究センター（大阪府）
羽生総合病院（埼玉県）
慶應義塾大学（東京都）
兵庫医科大学（兵庫県）
東京女子医科大学（東京都）
筑波大学（茨城県）
太田綜合病院附属西ノ内病院（福島県）
琉球大学（沖縄県）

Date of disclosure of the study information

2015

Year

07

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

479

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

2015

Year

05

Month

21

Day

Date of IRB

2015

Year

06

Month

01

Day

Anticipated trial start date

2015

Year

08

Month

01

Day

Last follow-up date

2020

Year

12

Month

24

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

07

Month

27

Day

Last modified on

2023

Year

01

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021348