Unique ID issued by UMIN | UMIN000017625 |
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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 |
Efficacy and safety of sodium-glucose cotransporter-2 inhibitor in patients with type 2 diabetes
ESSENTIAL STUDY
Efficacy and safety of sodium-glucose cotransporter-2 inhibitor in patients with type 2 diabetes
ESSENTIAL STUDY
Japan |
Type 2 diabetes mellitus
Cardiology | Endocrinology and Metabolism |
Others
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
HbA1c levels
glycoalbumin, FMD, blood pressure, biochemical parameters (including inflammation markers and urinary albumin)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
YES
Central registration
2
Treatment
Medicine |
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.
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.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
50
1st name | |
Middle name | |
Last name | Keijiro Saku |
Fukuoka University Hospital
Department of Cardiology
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
092-801-1011
miuras@cis.fukuoka-u.ac.jp
1st name | |
Middle name | |
Last name | Shin-ichiro Miura |
Fukuoka University Hospital
Department of Cardiology
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
092-801-1011
miuras@cis.fukuoka-u.ac.jp
Department of Cardiology, Fukuoka University Hospital.
Department of Cardiology, Fukuoka University Hospital.
Self funding
Japan
NO
福岡大学病院(福岡県)
2015 | Year | 05 | Month | 19 | Day |
Unpublished
Terminated
2014 | Year | 11 | Month | 27 | Day |
2014 | Year | 12 | Month | 01 | Day |
2016 | Year | 12 | Month | 31 | Day |
2015 | Year | 05 | Month | 19 | Day |
2019 | Year | 02 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020423
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