Unique ID issued by UMIN | UMIN000006537 |
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Receipt number | R000007726 |
Scientific Title | Examination of the optimal lipid-lowering therapy in patients with type 2 diabetes complicated with dyslipidemia |
Date of disclosure of the study information | 2011/10/19 |
Last modified on | 2012/03/05 14:34:18 |
Examination of the optimal lipid-lowering therapy in patients with type 2 diabetes complicated with dyslipidemia
Examination of the optimal lipid-lowering therapy in patients with type 2 diabetes complicated with dyslipidemia
Examination of the optimal lipid-lowering therapy in patients with type 2 diabetes complicated with dyslipidemia
Examination of the optimal lipid-lowering therapy in patients with type 2 diabetes complicated with dyslipidemia
Japan |
type 2 diabetes complicated with dyslipidemia
Endocrinology and Metabolism |
Others
NO
Type 2 diabetes complicated with dyslipidemia is well known to be a high risk of arteriosclerotic disease and several drug therapies are performed. No clinical trial has been performed to investigate what treatment of dyslipidemia should be received firstly for patients with type 2 diabetes. The aim of this study is to examine the differential effects on plasma lipid profile and blood sugar among ezetimibe and pravastatin utilizing cross-over design.
Efficacy
Change and percent change in TC, LDL-C, HDL-C, TG, Remnant like particle cholesterol (RLP-C), small dense LDL and FFA.
Change and percent change in HbA1c and insulin
Interventional
Cross-over
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Administration of ezetimibe 10mg in the first 3 to 4 months, after one week wash out period, followed by the administration of pravastatin 10mg.
Administration of pravastatin 10mg in the first 3 to 4 months, after one week wash out period, followed by the administration of ezetimibe 10mg.
20 | years-old | <= |
Not applicable |
Male and Female
Patients with type 2 diabetes complicated with dyslipidemia (not taking medication for hyperlipidemia, 120 mg / dl =< LDL in the serum lipid-C < 160 mg / dl, meets TG >= 150 mg / dl)
1)Patients with hypersensitivity against ezetimibe and pravastatin,
2)Patients with severe renal dysfunction and severe hepatic dysfunction,
3)Pregnant women, women who may be pregnant, and breast-feeding women.
4)Patients with drug-induced and familial dyslipidemia,
5)Patients treated with insulin
6)Patients judged by the investigator/ sub investigator to be ineligible for some other reason.
30
1st name | |
Middle name | |
Last name | Michiaki Fukui |
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Department of Endocrinology and Metabolism
465 Kajii-cho, Kawaramachi-Hirokoji,
1st name | |
Middle name | |
Last name |
Kyoto Prefectural University of
Department of Endocrinology and Metabolism
+81-75-251-5505
Department of Endocrinology and Metabolism Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Department of Endocrinology and Metabolism Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Self funding
NO
2011 | Year | 10 | Month | 19 | Day |
Unpublished
Open public recruiting
2011 | Year | 10 | Month | 20 | Day |
2011 | Year | 11 | Month | 01 | Day |
2011 | Year | 10 | Month | 13 | Day |
2012 | Year | 03 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007726
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