Unique ID issued by UMIN | UMIN000010703 |
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Receipt number | R000012509 |
Scientific Title | The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus |
Date of disclosure of the study information | 2013/05/13 |
Last modified on | 2019/10/16 15:52:31 |
The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus
The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus
The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus
The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus
Japan |
type 2 diabetes mellitus undergoing hemodialysis
Endocrinology and Metabolism | Nephrology |
Others
NO
The purpose of this study is to evaluate the effect of vildagliptin addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus.
Safety,Efficacy
Total daily dose of insulin and HbA1c(NGSP) at 0, 12 and 24 weeks after administration of vildagliptin
Mean amplitude of glycemic excursions
Safety and adherence
Events of hypoglycemia
Body weight
Observational
Not applicable |
Not applicable |
Male and Female
1)The patient who have poor glycemic control undergoing insulin therapy or judged that it was expectable to reduce the insulin dose in addition to vildagliptin
2)CPI<0.8
1) Severe ketosis, or diabetic coma or precoma, type1 diabetes
2) Severe liver dysfunction
3) Diarrhea or vomiting
4) Severe infection, before and after surgery, or severe trauma
5) History of lactic acidosis or pancreatitis
6) Severe cardiac or pulmonary dysfunction, such as shock, heart failure, myocardial infarction, and pulmonary embolism.
7) Dehydration
8) History of severe alcoholic abuse
9) Malnutrition, starvation, debility, pituitary dysfunction, and adrenal insufficiency
10) Pregnant female, female with possibility of pregnancy
11) Malignancy
12) History of hypersensitivity to targeted medication
13) Patients inappropriate for medical reason
40
1st name | |
Middle name | |
Last name | Kazuaki Soejima |
Saiseikai Kumamoto Hospital
Kidney and Urology center
5-3-1 Chikami Minami-ku Kumamoto
096-351-8000
kazuaki-soejima@saiseikaikumamoto.jp
1st name | |
Middle name | |
Last name | Hironobu Inoue |
Saiseikai Kumamoto Hospital
Kidney and Urology center
5-3-1 Chikami Minami-ku Kumamoto
096-351-8000
hironobu-inoue@saiseiakikumamoto.jp
Saiseikai Kumamoto Hospital
None
Self funding
NO
済生会熊本病院
2013 | Year | 05 | Month | 13 | Day |
Partially published
Completed
2013 | Year | 05 | Month | 01 | Day |
2013 | Year | 05 | Month | 13 | Day |
2013 | Year | 05 | Month | 13 | Day |
2014 | Year | 05 | Month | 13 | Day |
2014 | Year | 05 | Month | 13 | Day |
2014 | Year | 05 | Month | 13 | Day |
2014 | Year | 12 | Month | 31 | Day |
The purpose of this study is to evaluate the effect of vildagliptin addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus.
2013 | Year | 05 | Month | 13 | Day |
2019 | Year | 10 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012509
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