Unique ID issued by UMIN | UMIN000050583 |
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Receipt number | R000057617 |
Scientific Title | Study for the efficacy and safety of oral semaglutide in subjects with type 2 diabetes -retrospective observation trial |
Date of disclosure of the study information | 2023/03/14 |
Last modified on | 2023/03/14 23:49:24 |
Study for the efficacy and safety of oral semaglutide in subjects with type 2 diabetes
Study for the usefulness and safety of oral semaglutide
Study for the efficacy and safety of oral semaglutide in subjects with type 2 diabetes -retrospective observation trial
Study for the usefulness and safety of oral semaglutide
Japan |
Type 2 diabetes
Medicine in general | Endocrinology and Metabolism |
Others
NO
To investigate the changes in glycemic control and body weight before and after semaglutide treatment in addition to safety analysis.
Safety,Efficacy
Exploratory
Pragmatic
Phase IV
1) The changes in HbA1c before and after semaglutide treatment
2) The safety of semaglutide especially regarding gastrointestinal symptoms and hypoglycemia
1) The change in body weight
2) The changes in plasma glucose, systolic/diastolic blood pressure, pulse rate, lipid metabolism, liver function, kidney function, proteinuria, and microalbuminuria after 6 months semaglutide treatment
3) The changes in drugs for diabetes, dyslipidemia, and hypertension after 6 months semaglutide treatment
4) Adverse effects
5) Patient background
6) The factors associated with improvement of HbA1c and body weight
7) Effects of continuation or discontinuation of anti-hyperglycemic agents other than semaglutide
8) Effects of medications for the comorbidities on body weight after semaglutide treatment
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Subjects with type 2 diabetes who were newly treated with oral-semaglutide between 2/5/2021 to 12/31/2022
1) Subjects for whom administration of oral semaglutide is contraindicated in the package insert (a history of hypersensitivity to the components of this drug, hyperglycemic emergencies such as diabetic ketoacidosis, severe infections)
2) Subjects who are inadequate to enter this study due to the other reasons by physician's judgments
500
1st name | Hiroshi |
Middle name | |
Last name | Nomoto |
Hokkaido University Hospital
Department of diabetology and endocrinology
060-0811
North 15 West 7, Kita-ku, Sapporo, Hokkaido, Japan
011-706-5915
hnomoto@med.hokudai.ac.jp
1st name | Hiroshi |
Middle name | |
Last name | Nomoto |
Hokkaido University Hospital
Department of diabetology and endocrinology
060-0811
North 15 West 7, Kita-ku, Sapporo, Hokkaido, Japan
011-706-5915
hnomoto@med.hokudai.ac.jp
Hokkaido University Hospital
None
Self funding
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
North 14, West 5, Kita-ku, Sapporo, Hokkaido, Japan
011-706-7636
crjimu@huhp.hokudai.ac.jp
NO
北海道大学病院(北海道)、青木内科クリニック(北海道)、栗原内科(北海道)、さっぽろ糖尿病・甲状腺クリニック(北海道)
2023 | Year | 03 | Month | 14 | Day |
Unpublished
Open public recruiting
2022 | Year | 10 | Month | 07 | Day |
2022 | Year | 10 | Month | 07 | Day |
2022 | Year | 10 | Month | 19 | Day |
2023 | Year | 08 | Month | 31 | Day |
Laboratory and physical examinations will be compared between week 0 and each examination time point (-6 months, -3 months, -1 month, 3 months, and 6 months after semaglutide administration). Regarding safety, all subjects who started semaglutide will be included. Analysis of other tests will be performed on a Per Protocol Set basis.
2023 | Year | 03 | Month | 14 | Day |
2023 | Year | 03 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057617
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