UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the effect of the incretin on cardiac function in patients with type 2 diabetes
Acronym	Incretin and cardiac function
Scientific Title	Investigation of the effect of the incretin on cardiac function in patients with type 2 diabetes
Scientific Title:Acronym	Incretin and cardiac function
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of incretin on cardiac function in patients with type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Change in cardiac function by echocardiography (including speckle tracking)
Key secondary outcomes	1) All cause death, 2)Cardiovascular events (composite of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal ischemic stroke, hospitalization for heart failure, coronary revascularization, or hospitalization for peripheral artery disease), 3) Change in fasting glucose, HbA1c, body weight, insluin resistance and secretion, BNP, Hs-CRP, lipids, PUFAs, UACA, CTR, ABI, cartid echography, and ECG.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	DPP4 inhibitor treatment group
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes
Key exclusion criteria	1) Allergy of Incretin related drug 2) Patients who receive DPP4 inhibitors or GLP-1 before starting study 3) Pregnant, lactating, possibly pregnant or planning to become pregnant women 4) Renal, hepatic, cardiovascular, thyroid, or hematological disease. 5) Malignant tumor 6) Patients considered as inadequate by the principal investigator
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Satoru Kishi
Organization	Mitsui Memorial Hospital
Division name	Division of diabetes
Zip code
Address	1 Kanda Izumicho, Chiyoda-ku, Tokyo
TEL	03-3862-9111
Email	skishi@mitsuihosp.or.jp

Public contact
Name of contact person	1st name Middle name Last name Satoru Kishi
Organization	Mitsui Memorial Hospital
Division name	Division of diabetes
Zip code
Address	1 Kanda Izumicho, Chiyoda-ku, Tokyo
TEL	03-3862-9111
Homepage URL
Email	m980287@gmail.com

Sponsor
Institute	Division of diabetes, Mitsui Memorial Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	社会福祉法人三井記念病院(東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 31 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	Completed
Date of protocol fixation	2014 Year 07 Month 01 Day
Date of IRB	2014 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 31 Day
Last follow-up date	2019 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 07 Month 31 Day
Last modified on	2020 Year 08 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017120