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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026766
Receipt No. R000030729
Scientific Title Prospective, randomized, open-label, clinical trial comparing the effects of exenatide and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Date of disclosure of the study information 2017/03/30
Last modified on 2017/03/29

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Basic information
Public title Prospective, randomized, open-label, clinical trial comparing the effects of exenatide and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Acronym Prospective, randomized, open-label, clinical trial comparing the effects of exenatide and sitagliptin
Scientific Title Prospective, randomized, open-label, clinical trial comparing the effects of exenatide and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Scientific Title:Acronym Prospective, randomized, open-label, clinical trial comparing the effects of exenatide and sitagliptin
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of exenatide versus sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hemoglobin A1C levels, glycoalbumin levels, blood glucose/lipids levels, and flow-mediated vasodilation in forearm
Twelve weeks after administration
Key secondary outcomes Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria)
Twelve weeks after administration

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of exenatide first, then change to sitagliptin (for 12 weeks each)
Interventions/Control_2 Administration of sitagliptin first, then change to exenatide (for 12 weeks each)
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Diabetic patients whose HbA1c levels are greater than 7, despite medical therapy including life style change/medications for at least 8 weeks
2) 20 years of age or older and 75 years of age or younger.
3) Female or Male
4) Outpatients
5) Subjects who gave written informed consent
Key exclusion criteria Allergy against exenatide /sitagliptin
2) Type I diabetes
3) Secondary diabetes
4) Poor-controlled diabetes (HbA1c>10.0 %)
5) Subjects who takes GLP-1 receptor agonist or DPP4 inhibitor.
6)History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
7) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits
8) renal insufficiency: serum creatinine>1.3 (male)>1.2(female)
9) Symptomatic (NYHA III or IV) congestive heart failure
10) Malignancies or other diseases with poor prognosis
11) Pregnant
12) Subjects whose doctor in charge do not agree to join the trial
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotaka Ezaki
Organization Tokorozawa Herat Center
Division name Department of Cardiology
Zip code
Address 2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN
TEL 0429408611
Email hirotakaezaki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Misa Ito
Organization Self-Defense Forces Fuji Hospital
Division name Department of Internal Medicine
Zip code
Address 481-27 Subashiri, Oyamatyo, suntougun, Shizuoka, JAPAN 410-1431
TEL 0550-75-2311
Homepage URL
Email jumpimjumpim@gmail.com

Sponsor
Institute Tokorozawa Heart Center
Institute
Department

Funding Source
Organization Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Self-Defense Forces Fuji Hospital
National defense medical college hospital
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 自衛隊富士病院

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 30 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 30 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
2017 Year 03 Month 29 Day
Last modified on
2017 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030729

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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