Unique ID issued by UMIN | UMIN000018740 |
---|---|
Receipt number | R000021674 |
Scientific Title | Effects of exenatide extended-release in patients with type 2 diabetes mellitus |
Date of disclosure of the study information | 2015/08/21 |
Last modified on | 2017/07/24 16:59:08 |
Effects of exenatide extended-release in patients with type 2 diabetes mellitus
Effects of exenatidein patients with type 2 diabetes mellitus
Effects of exenatide extended-release in patients with type 2 diabetes mellitus
Effects of exenatidein patients with type 2 diabetes mellitus
Japan |
type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To compare effects of exenatide and sitagliptine on blood pressure parameters in patients with type 2 diabetes mellitus.
Efficacy
The following outcomes are estimated 24 weeks after start of treatment:
- Changes in blood pressure by ambulatory blood pressure monitoring
- Changes in office blood pressure
- Ratios of patients requiring changes in doses or contents of medications
Changes in the following factors are estimated 24 weeks after start of treatment:
- fasting blood sugar and HbA1c
- inflammation: hsCRP
- renal function: urinary protein/creatinine ratio, urinary albumin/creatinine ratio, and eGFR
- renin-angiotensin system
Blood: plasma renin activity, aldosterone, prorenin, and soluble (pro)renin receptor. Urine: prorenin, soluble (pro)renin receptor, and angiotensinogen
- body weight, waist circumference, visceral fat area, and hANP
- endothelial function: flow-mediated dilation
- arterial stiffness: baPWV
Interventional
Cross-over
Randomized
Cluster
Open -no one is blinded
Active
2
Treatment
Medicine |
weekly subcutaneously injection of
2 mg exenatide extended-release for 24 weeks
oral administration of 50 mg of sitagliptin once daily for 24 weeks
20 | years-old | <= |
Not applicable |
Male and Female
- patients with type 2 diabetes mellitus
- normotensive patients or well-controlled hypertensive patients
- patients contraindicated to the study drugs
- patients treated with insulin
- patients with uncontrollable hypertension
- pregnant women or women who are possibly pregnant
100
1st name | |
Middle name | |
Last name | Atsuhiro Ichihara |
Tokyo Women's Medical University
Department of Medicine II
8-1 Kawada-cho, Shinjyuku-ku, Tokyo
03-3353-8111
atzichi@endm.twmu.ac.jp
1st name | |
Middle name | |
Last name | Satoshi Morimoto |
Tokyo Women's Medical University
Department of Medicine II
8-1 Kawada-cho, Shinjyuku-ku, Tokyo
03-3353-8111
smorimoto@endm.twmu.ac.jp
Tokyo Women's Medical University
Tokyo Women's Medical University
Self funding
NO
2015 | Year | 08 | Month | 21 | Day |
Unpublished
Terminated
2015 | Year | 08 | Month | 21 | Day |
2015 | Year | 08 | Month | 21 | Day |
2017 | Year | 07 | Month | 24 | Day |
2017 | Year | 07 | Month | 24 | Day |
2017 | Year | 07 | Month | 24 | Day |
2015 | Year | 08 | Month | 20 | Day |
2017 | Year | 07 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021674