UMIN-CTR Clinical Trial

Basic information
Public title	Effect of gulcose-lowering agents on adipocytokine levels in patients with diabetes mellitus
Acronym	Comparative study of ipragliflozin versus metformin on adipocytokine levels
Scientific Title	Effect of gulcose-lowering agents on adipocytokine levels in patients with diabetes mellitus
Scientific Title:Acronym	Comparative study of ipragliflozin versus metformin on adipocytokine levels
Region	Japan

Condition
Condition	type 2 diabetic patients with coronary artery disease
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the effect of ipragliflozin or metformin in combination with DPP4-inhibitors on adipocytokine levels in type 2 diabetic patients with coronary artery disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in adipocytokine
Key secondary outcomes	Changes in glucose metabolism Changes in body weight and abdominal circumference Changes in laboratory parameters Assessment of vascular event

Base
Study type	Interventional

Study design
Basic design	Parallel
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	group A: additive therapy of ipragliflozin 50-100mg once daily to DPP4 inhibitor for 6 months
Interventions/Control_2	Group B: additive therapy of metformin 250-750mg twice daily to DPP4 inhibitor for 6 months
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	18 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients who have a history of following coronary heart diseasese CABG or PCI was performed more than 6 months before >= 50% coronary artery stenosis according to the ACC/AHA classification was found by CAG 2) Diabetic patients under treatment of DPP-4 inhibitor more than 3 months 3) Patients who are judged to require the more glucose-lowering therapy
Key exclusion criteria	1) Patients with malignancy 2) Patients with history of hypersensitivity against DPP4 inhibitor, SGLT2 inhibitor, and biguanide drugs 3) patients whose glycemic control is extremely poor (HbA1c >=10%) 4) patients whose glycemic control is very poor (HbA1c >=10%) 5) Pregnant women, women who may be pregnant, and breast-feeding women. 6) Patients with history of renal transplantation, urinary infection, sexually transmission disease, and non-cardiogenic stroke 7) Patients who took diuretics 8) patients whose BMI is lower than 18.5 9) Patients with history of acute coronary syndrome within 6 months 10) Patients judged by the investigator/ sub investigator to be ineligible for some other reason
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masato Watarai
Organization	Anjo Kosei Hospital
Division name	Cardiovascular Center
Zip code
Address	28, Higashi-Hirokute, Anjo, Anjo, Aichi
TEL	0566-75-2111
Email	watarai@kosei.anjo.aichi.jp

Public contact
Name of contact person	1st name Middle name Last name Yusuke Uemura
Organization	Anjo Kosei Hospital
Division name	cardiovascular Center
Zip code
Address	28, Higashi-Hirokute, Anjo, Anjo, Aichi
TEL	0566-75-2111
Homepage URL
Email	yusuke0307@hotmail.com

Sponsor
Institute	Anjo Kosei Hospital, Cardiovascular Center
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

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 26 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	2015 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 04 Month 13 Day
Last modified on	2018 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019543

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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