Unique ID issued by UMIN | UMIN000002318 |
---|---|
Receipt number | R000002827 |
Scientific Title | Effect of ezetimibe/statin combination therapy in patients with type 2 diabetes and dyslipidemia on remnant and inflammation |
Date of disclosure of the study information | 2009/08/11 |
Last modified on | 2010/04/06 19:32:40 |
Effect of ezetimibe/statin combination therapy in patients with type 2 diabetes and dyslipidemia on remnant and inflammation
Ezetimibe/statin combination therapy in patients with type 2 diabetes
Effect of ezetimibe/statin combination therapy in patients with type 2 diabetes and dyslipidemia on remnant and inflammation
Ezetimibe/statin combination therapy in patients with type 2 diabetes
Japan |
type 2 diabetes with hypercholesterolemia
Endocrinology and Metabolism |
Others
NO
To examine the effect of ezetimibe on the serum levels of RLP-cholesterol and inflammation markers in type 2 diabetic patients with hypercholesterolemia who have been treated with statins.
Efficacy
Phase IV
Change of the serum levels of RLP- Cholesterol (4 months after initiaion of therapy)
Change of the serum levels of the following serum inflammatory markers and lipids(4 months after initiaion of therapy)
1)hsCRP, 2)IL-6, 3)IL-18, 4)apoB48, 5)total cholesterol, 6)LDL cholesterol, 7)HDL cholesterol, 8)triglyceride, 9)adiponectin, 10)TNFa, 11)insulin
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Ezetimibe (10mg) daily, for 4 months
20 | years-old | <= |
Not applicable |
Male and Female
Patients who meet all of the following criteria:
1) Patients with type 2 diabetes over 20 yeras old
2)Patients who have been treated with statins for more than 3 months
3)Patients whose serum LDL cholesterol levels do not reach the control target values of Japan Atherosclerosis Society Guideline 2007.
1)During pregnancy or lactation
2)Patients who had allergy to ezetimibe
3)Serious liver or renal diseases
4)Acute or chronic inflammatory diseases
5)Other conditions precluding participation as judged by the investigator
100
1st name | |
Middle name | |
Last name | Wataru Ogawa |
Kobe University Graduate School of Medicine
Division of Diabetes, Metabolism and Endocrinology
7-5-1 Kusunoki-cho, chuo-ku, Kobe
078-382-5861
1st name | |
Middle name | |
Last name | Wataru Ogawa |
Kobe University Graduate School of Medicine
Division of Diabetes, Metabolism and Endocrinology
7-5-1 Kusunoki-cho, chuo-ku, Kobe
078-382-5861
Kobe University Graduate School of Medicine, Division of Diabetes, Metabolism and Endocrinology
Kobe University Graduate School of Medicine, Division of Diabetes, Metabolism and Endocrinology
Self funding
Rokko Island Hspital, Konan Hospital, Shin-Suma Hospital, Obara Hospital, Sugano Clinic, Ooshiro Clinic, Amano Clinic, Osaka Koseinenkin Hospital
NO
2009 | Year | 08 | Month | 11 | Day |
Unpublished
2009 | Year | 08 | Month | 04 | Day |
2009 | Year | 08 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2009 | Year | 08 | Month | 10 | Day |
2010 | Year | 04 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002827
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |