UMIN-CTR Clinical Trial

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	30
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	No longer 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	2020 Year 05 Month 25 Day

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