Unique ID issued by UMIN | UMIN000044159 |
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Receipt number | R000050374 |
Scientific Title | efficacy of semaglutide vs dulaglutide in type 2 diabetes mellitus patients on Hemodialysis |
Date of disclosure of the study information | 2021/05/10 |
Last modified on | 2023/03/10 14:58:09 |
efficacy of semaglutide vs dulaglutide in type 2 diabetes mellitus patients on Hemodialysis
efficacy of semaglutide vs dulaglutide in type 2 diabetes mellitus patients on Hemodialysis
efficacy of semaglutide vs dulaglutide in type 2 diabetes mellitus patients on Hemodialysis
efficacy of semaglutide vs dulaglutide in type 2 diabetes mellitus patients on Hemodialysis
Japan |
Type 2 diabetes
Medicine in general | Endocrinology and Metabolism |
Others
NO
For outpatients with type 2 diabetes who are using dulaglutide but need glycemic control, switch to semaglutide and Use Continuous Glucose Monitoring (CGM) to compare and evaluate differences in glycemic control on dialysis and non-dialysis days.
Efficacy
Percentage of CGM blood glucose 70-180 mg / dl (normal range) time for 3 days each on HD and non-HD days for each treatment
(1) Percentage of CGM blood glucose level <70 mg / dl (hypoglycemic range) and blood glucose level <54 mg / dl (severe hypoglycemic range) for 3 days each on HD and non-HD days in each treatment method Percentage, blood glucose level 180 mg / dl or higher (hypoglycemic range) time percentage, average blood glucose level, SD value, CV value, M value, MAGE,(2) Changes in HbA1c and glycoalbumin levels, (3) BMI at the end of HD on weekends, (4) BW with one non-dialysis day and BW with two non-dialysis days, (5) Weekend Changes in hANP value after dialysis.
Observational
20 | years-old | <= |
80 | years-old | > |
Male and Female
1. Age: 20 years old or older and under 80 years old. 2. Gender: No matter. 3. Those who have been diagnosed with type 2 diabetes more than 1 year before the start of the study and have been treated with dulaglutide for more than 3 months before the screening.4. Glycoalbumin (GA) 20% or more. 5. Those who have passed more than 6 months since the introduction of hemodialysis. 6. A person who has received sufficient explanation for participating in this research, and who has obtained the consent of the document by his / her free will after sufficient understanding.
7. Those who can go to the outpatient clinic according to the research implementation schedule
1. Patients with a history of severe ketosis, diabetic coma or precoma within 6 weeks of the start of the study. 2. Patients who develop severe hypoglycemia (diabetic coma or precoma, convulsions, etc. that require the assistance of a third party) within 6 weeks of the start of the study.
3. Patients with a history of chronic or idiopathic acute pancreatitis. 4. Patients with a history of acute coronary or cerebrovascular events within 90 days, NYHA class IV heart failure. 5. Patients with proliferative retinopathy (However, patients who have undergone photocoagulation and have stable symptoms can be included). 6. Patients with a history of surgery for serious gastrointestinal disorders. 7. Pregnant or potentially pregnant women and lactating patients. 8. Patients with severe infections, before and after surgery, and with serious trauma. 9. Patients receiving systemic corticosteroids. 10. Patients with severe liver dysfunction (high AST or ALT of 100 U / L or more). 11. Patients with a history of allergies to the drugs to be used in the study. 12. Patients with malignant tumor or history of malignant tumor. 13. Other patients judged by the investigator to be inappropriate as subjects.
24
1st name | yasuro |
Middle name | |
Last name | kumeda |
minamiosakahospital
Internal medicine
5590012
1-18-18 Higashikagaya, Suminoe-ku, Osaka-shi, Osaka
06-6685-0221
y_kumeda@yahoo.co.jp
1st name | shoko |
Middle name | |
Last name | miyamoto |
minamiosakahospital
Internal medicine
5590012
1-18-18 Higashikagaya, Suminoe-ku, Osaka-shi, Osaka
06-6685-0221
sh0k0.w.0128@gmail.com
minamiosakahospital, Internal medicine
minamiosakahospital
Other
minamiosakahospital
1-18-18 Higashikagaya, Suminoe-ku, Osaka-shi, Osaka
06-6685-0221
houjinhonbu@minamiosaka.com
NO
南大阪病院(大阪府)
2021 | Year | 05 | Month | 10 | Day |
Published
7
The number of participants was 7. 3 had difficulty continuing participation. The percentage of time in the normal range of CGM on HD and non-HD days decreased and the glycoalbumin level decreased before and 8 weeks after the start of the study. The percentage of time in the hypoglycemic range increased, the percentage of time in the hyperglycemic range increased, SD values decreased, and BMI at the end of the HD weekend showed little change.
2022 | Year | 05 | Month | 11 | Day |
2022 | Year | 05 | Month | 11 | Day |
Average age 62.6 years, 5 males (1 female), average BMI 24.37, average 6.1 years after introduction of dialysis, 1 person using insulin as a combination drug, 1 person using meglitinide.
Completed
2021 | Year | 03 | Month | 28 | Day |
2021 | Year | 02 | Month | 02 | Day |
2021 | Year | 05 | Month | 10 | Day |
2022 | Year | 03 | Month | 31 | Day |
minamiosakahospital
2021 | Year | 05 | Month | 10 | Day |
2023 | Year | 03 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050374
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