UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective, randomized, open-label, clinical trial comparing the effects of exenatide and sitagliptin on glucose/lipids metabolism and endothelial function in diabetic patients
Title of the study (Brief title)	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	Hirotaka Ezaki
Organization	Tokorozawa Herat Center
Division name	Department of Cardiology
Address	2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN
TEL	0429408611
Email	hirotakaezaki@gmail.com

Public contact
Name of contact person	Misa Ito
Organization	Self-Defense Forces Fuji Hospital
Division name	Department of Internal Medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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