Unique ID issued by UMIN | UMIN000025418 |
---|---|
Receipt number | R000029259 |
Scientific Title | Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes. |
Date of disclosure of the study information | 2016/12/26 |
Last modified on | 2020/07/14 18:57:22 |
Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.
Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.
Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.
Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.
Japan |
Type 2 diabetes
Medicine in general | Endocrinology and Metabolism | Adult |
Others
NO
The aim of this study is to compare a SGLT2 inhibitor Empagliflozin and other anti diabetic agents on lipid parameter and lipid metabolism in patients with type 2 diabetes.
Safety,Efficacy
sterol 3 fractions
sterol fractionate
Triglyceride
DUAL-scan
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Numbered container method
2
Treatment
Medicine |
Empagliflozin group
control group
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 7.0 and 12.4 %) under medical treatment by dieting and exercise cure and/or drug treatment.
2)Over 20 years old and less than 80 years old
3)Sex unquestioned
4)Patients with no history of cardiovascular disease
5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization.
6)The patient who gives a written informed
1)Type 1 diabetes
2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges)
3)A pregnant woman and/or a woman under breast-feeding
4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)
5)Diabetic proliferative retinopathy
6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug
7)No treatment with Ezetimibe
8)Patient with intolerance of medical reasons by doctor.
30
1st name | Teruo |
Middle name | |
Last name | Teruo Joijma |
Dokkyo Medical University
Department of Endocrinology and Metabolism
321-0293
880kita-kobayashi,Mibu,Tochigi321-0293,Japan
0282-87-2150
jojima@dokkyomed.ac.jp
1st name | Teruo |
Middle name | |
Last name | Teruo Joijma |
Dokkyo Medical University
Department of Endocrinology and Metabolism
321-0293
880kita-kobayashi,Mibu,Tochigi321-0293,Japan
0282-87-2150
jojima@dokkyomed.ac.jp
Department of Endocrinology and Metabolism,
Dokkyo Medical University
none
Self funding
Dokkyo Medical University
880kita-kobayashi,Mibu,Tochigi,Japan
0282-87-2275
r-kenkyu@dokkyomed.ac.jp
NO
2016 | Year | 12 | Month | 26 | Day |
Unpublished
Open public recruiting
2016 | Year | 04 | Month | 01 | Day |
2016 | Year | 04 | Month | 01 | Day |
2016 | Year | 12 | Month | 26 | Day |
2020 | Year | 07 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029259
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |