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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032705
Receipt No. R000037294
Scientific Title Prospective, randomized, open-label, clinical trial comparing the effects of dapagliflozin and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Date of disclosure of the study information 2018/05/24
Last modified on 2019/05/27

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

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of dapagliflozin 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 -no one is 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 dapagliflozin first, then change to sitagliptin (for 12 weeks each)
Interventions/Control_2 Administration of dapagliflozin 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
80 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 1) Allergy against dapagliflozin/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 Makoto
Middle name
Last name Ayaori
Organization Tokorozawa Heart Center
Division name Shintokoekimae Clinic
Zip code 359-1111
Address 1-4-1-101 Midoricho, Tokorozawa, Japan 359-1111
TEL 0429291801
Email ayaori@ba2.so-net.ne.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Ayaori
Organization Tokorozawa Heart Center
Division name Shintokoekimae Clinic
Zip code 359-1111
Address 1-4-1-101 Midoricho, Tokorozawa, Japan 359-1111
TEL 0429291801
Homepage URL
Email ayaori@ba2.so-net.ne.jp

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
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokorozawa Heart Center IRB
Address 2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
Tel 04-2940-8611
Email cs.thc@oukai.or.jp

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
2018 Year 05 Month 24 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
2018 Year 05 Month 16 Day
Date of IRB
2018 Year 04 Month 19 Day
Anticipated trial start date
2018 Year 05 Month 24 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 24 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037294

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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