Unique ID issued by UMIN | UMIN000024001 |
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Receipt number | R000027609 |
Scientific Title | A randomized comparison of the effect of empagliflozin for endothelial function in type 2 diabetes |
Date of disclosure of the study information | 2016/09/12 |
Last modified on | 2022/03/17 15:37:27 |
A randomized comparison of the effect of empagliflozin for endothelial function in type 2 diabetes
The effect of empagliflozin for endothelial function
A randomized comparison of the effect of empagliflozin for endothelial function in type 2 diabetes
The effect of empagliflozin for endothelial function
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To examine the effect of empagliflozin for endothelial function in type 2 diabetes.
Efficacy
Change of FMD% with additional treatment before and after 12 weeks
1.Change of them with additional treatment before and after 12 weeks
Fasting plasma glucose
Postprandial plasma glucose
HbA1c
GA
Fasting CPR
Renal function
Urinary albumin
L-FABP
UA
Body weight
Waist
BMI
Blood pressure
Heart rate
Lipid profile(TC, TG, HDL-C, LDL-C)
Body domposition(Body fluid volume, Skeletal muscle mass, Total fat mass)
2.Adverese event
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Empagliflozin group:
Metformin and glargine before bedtime for 12 weeks, then empagliflozin 10 mg was added for 12 weeks. FMD was measured before and after additional treatment.
Glimepiride group:
Metformin and glargine before bedtime for 12 weeks, then glimepiride 0.5 mg was added for 12 weeks. FMD was measured before and after additional treatment.
20 | years-old | <= |
80 | years-old | > |
Male and Female
1.Inpatients with Type 2 diabetes at Chigasaki municipal hospital
2.Patients treated with metformin and basal insulin in leaving hospital
3.Age lower limit 20, upper limit 80
4.BMI <= 45 kg/m2
5.Patients gave written consent to participate in this study
1.Patients with severe renal dysfunction (eGFR < 45 ml/min/1.73m2)
2.Patients with severe liver dysfunction
3.Patients have history of cardiovascular disease and cerebral infarction within 24 weeks
4.Patients taking steroid
5.Patients with cancer
6.Patients with severe infection and trauma
7.Patients are pregnant or have possibility of pregnancy
8.Patients have an allergy to empagliflozin, glimepiride, glargine and metformin
9.Patients considered inappropriate to participate in this study by the doctor in charge
80
1st name | Shinobu |
Middle name | |
Last name | Satoh |
Chigasaki Municipal Hospital
Division of Endocrinology & Metabolism
2530042
5-15-1, Honson, Chigasaki, Kanagawa
0467-52-1111
shinobu@medical.email.ne.jp
1st name | Haruka |
Middle name | |
Last name | Tamura |
Chigasaki Municipal Hospital
Division of Endocrinology & Metabolism
2530042
5-15-1, Honson, Chigasaki, Kanagawa
0467-52-1111
t166054a@yokohama-cu.ac.jp
Chigasaki Municipal Hospital
None
Self funding
Chigasaki Municipal Hospital
5-15-1, Honson, Chigasaki, Kanagawa
0467-52-1111
shinobu@medical.email.ne.jp
NO
茅ヶ崎市立病院(神奈川県)
2016 | Year | 09 | Month | 12 | Day |
Unpublished
Completed
2016 | Year | 04 | Month | 22 | Day |
2016 | Year | 04 | Month | 22 | Day |
2016 | Year | 09 | Month | 13 | Day |
2019 | Year | 06 | Month | 14 | Day |
2016 | Year | 09 | Month | 10 | Day |
2022 | Year | 03 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027609
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