Unique ID issued by UMIN | UMIN000022804 |
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Receipt number | R000026282 |
Scientific Title | The efficacy of SGLT2 inhibitor switching from thiazolidine about body weight and metabolic-related factors in type 2 diabetes patients |
Date of disclosure of the study information | 2016/06/20 |
Last modified on | 2018/11/28 17:51:26 |
The efficacy of SGLT2 inhibitor switching from thiazolidine about body weight and metabolic-related factors in type 2 diabetes patients
The efficacy of SGLT2 inhibitor switching from thiazolidine in type 2 diabetes patients
The efficacy of SGLT2 inhibitor switching from thiazolidine about body weight and metabolic-related factors in type 2 diabetes patients
The efficacy of SGLT2 inhibitor switching from thiazolidine in type 2 diabetes patients
Japan |
type 2 diabetes
Medicine in general | Endocrinology and Metabolism |
Others
NO
In type 2 diabetes patients during the treatment in the treatment of diabetes, including Pioglitazone, to assess the efficacy of SGLT2 inhibitor Dapagliflozin about body weight, changes in blood glucose control, lipid, blood pressure, and metabolic-related factors, such as liver function influence by switching Pioglitazone into Dapagliflozin.
Efficacy
Confirmatory
Pragmatic
Phase IV
Body weight and HbA1c at 24 weeks
Abdominal circumference
Blood pressure
Lipid metabolism
Liver function
Complete blood count, renal function, electrolyte
Urine test
Frequency of hypoglycemia
Dose of antidiabetic drugs before and during clinical trial
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Keeping Pioglitazone
Switching Pioglitazone to Dapagliflozin
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Age: 20 to 80 years old
2) HbA1c: 6.0-8.5%
3) BMI: 23 kg/m^2 and more
4) eGFR: 45ml/min/1.73m^2 and more
5) Taking Pioglitazone(15-30 mg per day) for more than 12 weeks
6) Written informed consent
1) Already taking SGLT2 inhibitor agents
2) With hypersensitivity to Dapagliflozin
3) With severe or unstable retinopathy
4) With severe liver or kidney disfunction
5) With severe diabetic ketosis, pre-coma, or coma
6) With severe infection or trauma, or in perioperation
7) With pregnancy
8) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
70
1st name | |
Middle name | |
Last name | Hideaki Miyoshi |
Hokkaido Unverstiy Hospital
Department of Internal Medicine II
n14w5, Kita-ku, Sapporo, Hokkaido, Japan
011-706-5915
hmiyoshi@med.hokudai.ac.jp
1st name | |
Middle name | |
Last name | Kyu Yong Cho |
Hokkaido Unverstiy Hospital
Department of Internal Medicine II
n14w5, Kita-ku, Sapporo, Hokkaido, Japan
011-706-5915
kyuyong-cho@med.hokudai.ac.jp
Hokkaido Unverstiy Hospital
Hokkaido Unverstiy Hospital
Japanese Governmental office
NO
北海道大学病院(北海道)、栗原内科(北海道)、青木内科(北海道)、釧路赤十字病院(北海道)、苫小牧市立病院(北海道)、北海道中央労災病院せき損センター(北海道)、萬田記念病院(北海道)
2016 | Year | 06 | Month | 20 | Day |
Published
https://onlinelibrary.wiley.com/doi/full/10.1111/dom.13557
Completed
2016 | Year | 06 | Month | 13 | Day |
2016 | Year | 07 | Month | 01 | Day |
2016 | Year | 06 | Month | 20 | Day |
2018 | Year | 11 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026282
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