UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective, randomized, open-label, clinical trial evaluating the effects of dipeptidyl peptidase-4 (DPP4) inhibitors on progression of atherosclerotic plaques and endothelial function in type 2 diabetic patients
Title of the study (Brief title)	Clinical trial evaluating the effects of dipeptidyl peptidase-4 (DPP4) inhibitors
Region	Japan

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

Objectives
Narrative objectives1	To compare therapies with or without DPP4 inhibotors on atherosclerotic plaques progression and endothelial function in type 2 diabetic patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Area and thickness of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI) 12/24 months after randomization (2) Flow-mediated vasodilation in forearm 6 months after randomization
Key secondary outcomes	(1) Ankle/brachial index and cardio ankle vascular index (2) Markers for diabetes (hemoglobin A1c, glycoalbumin, blood glucose) (3) Serum lipids (4) Markers indicating obesity (e.g. adiponectin) (5) Markers indicating inflammation (e.g. high sensitive CRP) (6) Markers indicating oxidative stress (8-OHdG/ MDA-LDL) (7) Markers indicating chronic renal diseases (urine albumin/L-FABP) (8) Blood/urine urate levels (9) Body weight/waist circumference (10) blood pressures

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	Treatment for type 2 diabetes with DPP4 inhibitors
Interventions/Control_2	Treatment for type 2 diabetes without DPP4 inhibitors
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) Type 2 diabetic patients who should be treated with anti-diabetic agents recommended by Japan Diabetes Society Guidelines 2) Patients who have aortic atherosclerotic plaques detected by MRI 3) Outpatients 4) Subjects who gave written informed consent
Key exclusion criteria	1) Allergy against DPP4 inhibitors 2) Type 1 diabetes or patients with positive anti-islet antibodies 3) Secondary diabetes 4) Poor-controlled diabetes (HbA1c>10.0 %) 5) Under administration of DPP-4 inhibitors or GLP-1 agonists 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 exceeds three-fold of the normal limits 8) End stage renal disease 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	66

Research contact person
Name of lead principal investigator	Katsunori Ikewaki
Organization	National Defense Medical College
Division name	Department of Internal Medicine
Address	3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL	04-2995-1617
Email	katsunorike@ndmc.ac.jp

Public contact
Name of contact person	Makoto Ayaori
Organization	National Defense Medical College
Division name	Department of Internal Medicine
Address	3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL	04-2995-1617
Homepage URL
Email	ayaori@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
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)

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 09 Month 14 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 30 Day
Anticipated trial start date	2013 Year 09 Month 14 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	2013 Year 09 Month 13 Day
Last modified on	2018 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013739