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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009948
Receipt No. R000011569
Scientific Title Effect of sitagliptin on vascular endothelial function in Type 2 diabetes
Date of disclosure of the study information 2013/02/04
Last modified on 2017/08/15

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Basic information
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
Condition Type 2 diabetes
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 04 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
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
Other related information

Management information
Registered date
2013 Year 02 Month 04 Day
Last modified on
2017 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011569

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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