UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017625
Receipt number 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 17:55:35

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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 or person

Institute

Department of Cardiology, Fukuoka University Hospital.

Institute

Department

Personal name



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

Value
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