UMIN-CTR Clinical Trial

Public title

Effect of sitagliptin on vascular endothelial function in Type 2 diabetes

Acronym

Effect of sitagliptin on vascular endothelial function in Type 2 diabetes

Scientific Title

Effect of sitagliptin on vascular endothelial function in Type 2 diabetes

Scientific Title:Acronym

Effect of sitagliptin on vascular endothelial function in Type 2 diabetes

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The effect on improving vascular endothelial function in Type 2 diabetes treated with PCI will be investigated. We compare the effectiveness of sitagliptin to glimepiride with Endo-PAT

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The changes in RH-PAT scores with Endo-PAT during 9 months

Key secondary outcomes

1)The changes in HMR(index of coronary peripheral circulation) from first PCI to 9 months
2)The rate of spasm with intracoronary acetylcholine after 9 months
3)The changes of following data during 9 months
8-OHdG,OPG,high sensitivity CRP
CRP,small dense-LDL,high molecular adiponectin,RLP-C,NT-proBNP,TNF-a,IL-6
4)The changes in following data during 3,6,9 monnths
HbA1c,fasting blood glucose,insulin,TC,HDL-C,TG,serum creatinine,urinary albumin excretion,eGFR
5)The changes in following data during 9 months
echocardiographic study, PWV
6)The changes in following data and the frequency of following clinical condition
Office blood pressure,body weight and frequency of significant variationof body weight, The frequency of hypoglycemia symptom

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sitagliptin treatment Group;
First,starting sitagliptin treatment with 50mg. After 3 months,if the effect is not enough, raising sitagliptin dose to 100 mg. After additional 3 months,if the effect is not enough, adding combined medicine(other than SU and glinide)

Interventions/Control_2

Glimepiride treatment Group;
First,starting glimepiride treatment with 0.5mg. After 3 months,if the effect is not enough, raising glimepiride dose to 1.0 mg. After additional 3 months,if the effect is not enough, adding combined medicine(other than DPP-4 inhibitors and glinide)

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

30

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Thirty years old or older
2)Patients treated PCI
3)Type 2 diabetes patients (HbA1c higher 6.5% below 8.4%)
4)Written consent for participation in this study

Key exclusion criteria

1)Type 1 diabetes patients
2)Severe diabetic ketosis,diabetic coma,total coma
3)Severe infectious disease ,before or after surgery,and sever trauma
4)Severe renal dysfunction (eGFR<30mL/min or artificial dialysis)
5)cerebral infarction,cerebral apoplexy,subarachnoid bleeding,TIA in 3 months
6)Moderate or severe heart failure (NYHA III or IV)
7)Under treatment with oral diabetic medicine
8)Under treatment with insulin
9)Pregnant,lactating, possibly pregnant or planning to become pregnant women
10)Past medical history of hypersensitivity to sitagliptin or glimepiride
11)Patient considered as inadequate by the principal investigator

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Nobuhisa Hagiwara

Organization

Tokyo Women's Medical University

Division name

Cardiology

Zip code

Address

8-1 Kawadacho,Shinjuku-ku,Tokyo

TEL

03-3353-8111

Email

mhagi@hij.twmu.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroyuki Arashi

Organization

Tokyo Women's Medical University

Division name

Cardiology

Zip code

Address

8-1 Kawadacho,Shinjuku-ku,Tokyo

TEL

03-3353-8111

Homepage URL

Email

arahiro3130@gmail.com

Institute

Tokyo Women's Medical University

Institute

Department

Personal name

Organization

Tokyo Women's Medical University

Organization

Division

Category of Funding Organization

Self funding

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

2013

Year

02

Month

04

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

2013

Year

01

Month

11

Day

Date of IRB

Anticipated trial start date

2013

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

02

Month

04

Day

Last modified on

2017

Year

08

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011569