Unique ID issued by UMIN | UMIN000019031 |
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Receipt number | R000022007 |
Scientific Title | Efficacy and safety of dulaglutide when used instead of exenatide extended-release in type 2 diabetic patients |
Date of disclosure of the study information | 2015/09/16 |
Last modified on | 2019/05/10 23:52:28 |
Efficacy and safety of dulaglutide when used instead of exenatide extended-release in type 2 diabetic patients
Efficacy and safety of dulaglutide when used instead of exenatide extended-release in type 2 diabetic patients
Efficacy and safety of dulaglutide when used instead of exenatide extended-release in type 2 diabetic patients
Efficacy and safety of dulaglutide when used instead of exenatide extended-release in type 2 diabetic patients
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism | Adult |
Others
NO
The aim of this study is to compare efficacy and safety of dulaglutide with exenatide extended-release in type 2 diabetes mellitus patients who are formerly treated with exenatide extended-release
Safety,Efficacy
Pragmatic
Not applicable
Change of HbA1c,body weight at the 26th and the 52th week.
Ratio of dulaglutide/exenatide-extended-release which patients choose.
Change of data shown below at the 26th and the 52th week.
AST, ALT, gamma-GTP, LDL-C, HDL-C,TG, non-HOL-C, serum creatinine, serum UA, eGFR, 1,5-AG, self-monitoring blood glucose, Urine albumin(mg/gCr),Urine protein (g/gCr)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
The patients are treated with dulaglutide instead of exenatide extended-release from the start to the 26th week.On the 26th week the patients choose a drug from exenatide extended-release and dulaglutide and are treated with that up to the 52th week.
20 | years-old | <= |
90 | years-old | >= |
Male and Female
Type 2 diabetic patients treated with exenatide extended-release
HbA1c is higher than or equal to 6.0%
Patients are not planned to be treated with prohibited combined drugs
Type 1 diabetic patients.
Patients with a history of severe ketosis or diabetic coma in previous 6 months.
Patients with severe infection, before/after surgery or severe traumatic injury.
Patients to have a plan to be pregnant.
Patients with severe gastroenteric disturbance as exemplified by severe gastro-paresis.
Patients with a history of pancreatitis.
40
1st name | |
Middle name | |
Last name | Tatsuya Haga |
Haga Diabetes Clinic
internal medicine
3514-1 Teigaishinden Nishiho-cho Aisai Aichi Japan
0567-28-7700
tatsuya-umin@hagadm.com
1st name | |
Middle name | |
Last name | Tatsuya Haga |
Haga Diabetes Clinic
internal medicine
3514-1 Teigaishinden Nishiho-cho Aisai Aichi Japan
0567-28-7700
tatsuya-umin@hagadm.com
Haga Diabetes Clinic
None
Self funding
NO
羽賀糖尿病内科(愛知県)
2015 | Year | 09 | Month | 16 | Day |
Unpublished
Completed
2015 | Year | 09 | Month | 15 | Day |
2015 | Year | 09 | Month | 15 | Day |
2015 | Year | 09 | Month | 16 | Day |
2018 | Year | 12 | Month | 31 | Day |
2018 | Year | 12 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 09 | Month | 30 | Day |
2015 | Year | 09 | Month | 15 | Day |
2019 | Year | 05 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022007
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