UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of sodium-glucose cotransporter-2 inhibitor in patients with type 2 diabetes
Title of the study (Brief title)	ESSENTIAL STUDY
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Patients with uncontrolled blood sugar levels after dipeptidyl peptidase-4 inhibitor (DPP-4I) therapy in addition to coronary artery disease and/or high risk are enrolled. The patients are divided into two groups; combination with DPP-4I and sodium-glucose cotransporter-2 inhibitor (SGLT-2I) therapy group and double doses of DPP-4I therapy group.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	HbA1c levels
Key secondary outcomes	glycoalbumin, FMD, blood pressure, biochemical parameters (including inflammation markers and urinary albumin)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients with uncontrolled blood sugar after middle dose of DPP-4I treatment in addition to coronary artery disease and/or high risk are enrolled. The patients receive combination with middle dose of DPP-4I and SGLT-2 inhibitor.
Interventions/Control_2	Patients with uncontrolled blood sugar after middle dose of DPP-4I treatment in addition to coronary artery disease and/or high risk are enrolled. The patients receive double dose of DPP-4I.
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	1.Patients with HbA1c = or > 7.0 % after treatment of middle dose of DPP-4I more than 8 weeks. 2.Patients with coronary artery disease and/or high risk. 3.Patients who give their informed consent to participate for the present study.
Key exclusion criteria	1.Severe ketosis and diabetic coma 2.Type 1 diabetes mellitus 3.Severe liver dysfunction 4.Severe renal dysfunction 5.Pregnancy or lactation in women 6.Patients with a history of allergy to any component of the study medications 7.Patients corresponding to the contraindication of study medications 8.Ineligible patients according to the judgment by physician
Target sample size	50

Research contact person
Name of lead principal investigator	Keijiro Saku
Organization	Fukuoka University Hospital
Division name	Department of Cardiology
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL	092-801-1011
Email	miuras@cis.fukuoka-u.ac.jp

Public contact
Name of contact person	Shin-ichiro Miura
Organization	Fukuoka University Hospital
Division name	Department of Cardiology
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL	092-801-1011
Homepage URL
Email	miuras@cis.fukuoka-u.ac.jp

Sponsor
Institute	Department of Cardiology, Fukuoka University Hospital.
Institute
Department

Funding Source
Organization	Department of Cardiology, Fukuoka University Hospital.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	福岡大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 11 Month 27 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
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	2015 Year 05 Month 19 Day
Last modified on	2019 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020423