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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017625
Receipt No. R000020423
Scientific Title Efficacy and safety of sodium-glucose cotransporter-2 inhibitor in patients with type 2 diabetes
Date of disclosure of the study information 2015/05/19
Last modified on 2019/02/14

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Basic information
Public title Efficacy and safety of sodium-glucose cotransporter-2 inhibitor in patients with type 2 diabetes
Acronym ESSENTIAL STUDY
Scientific Title Efficacy and safety of sodium-glucose cotransporter-2 inhibitor in patients with type 2 diabetes
Scientific Title:Acronym 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
1st name
Middle name
Last name Keijiro Saku
Organization Fukuoka University Hospital
Division name Department of Cardiology
Zip code
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
1st name
Middle name
Last name Shin-ichiro Miura
Organization Fukuoka University Hospital
Division name Department of Cardiology
Zip code
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)

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 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

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 Terminated
Date of protocol fixation
2014 Year 11 Month 27 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020423

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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