Unique ID issued by UMIN | UMIN000051448 |
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Receipt number | R000054524 |
Scientific Title | Oral semaglutide vs DPP-4i on body weight in Japanese people with type 2 diabetes |
Date of disclosure of the study information | 2023/06/26 |
Last modified on | 2023/06/27 09:22:37 |
Oral semaglutide vs DPP-4i on body weight in Japanese people with type 2 diabetes
OSCAR-DWD study
Oral semaglutide vs DPP-4i on body weight in Japanese people with type 2 diabetes
OSCAR-DWD study
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
The aim of this study is to compare a GLP-1 receptor analogue Oral semaglutide and other DPP4 inhibitor on changes in body weight and other parameter in patients with type 2 diabetes.
Safety,Efficacy
Weight change after 24 weeks
Changes in HbA1c, urinary albumin (UACR), and blood pressure after 24 weeks
BNP, body composition, electrocardiogram (CVR-R), serum HMV adiponectin, serum sDPP-4 (sCD26), DTBQ score changes
PAI-1,
TAT, PIC, insulin, C-peptide, glucagon, blood amino acid fraction
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
2
Treatment
Medicine |
oral semaglutide group
control group
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 6.5 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 other GLP-1R analogue
8)Patient with intolerance of medical reasons by doctor.
70
1st name | Teruo |
Middle name | |
Last name | Jojima |
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 | Jojima |
Dokkyo Medical University
Department of Endocrinology and Metabolism
321-0293
880kita-kobayashi,Mibu,Tochigi321-0293,Japan
0282-87-2150
jojima@dokkyomed.ac.jp
Dokkyo Medical University
Department of Endocrinology and Metabolism
self funding
Self funding
Dokkyo Medical University
880kita-kobayashi,Mibu,Tochigi321-0293,Japan
0282-87-2275
r-kenkyu@dokkyomed.ac.jp
NO
2023 | Year | 06 | Month | 26 | Day |
Unpublished
Open public recruiting
2022 | Year | 04 | Month | 01 | Day |
2023 | Year | 06 | Month | 13 | Day |
2022 | Year | 05 | Month | 23 | Day |
2026 | Year | 03 | Month | 31 | Day |
2023 | Year | 06 | Month | 26 | Day |
2023 | Year | 06 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054524
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