Unique ID issued by UMIN | UMIN000008344 |
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Receipt number | R000009773 |
Scientific Title | The impact of DPP-4 inhibitor on daily glucose profile and coronary plaque character in diabetic patients with coronary artery disease |
Date of disclosure of the study information | 2012/07/04 |
Last modified on | 2022/04/25 10:50:58 |
The impact of DPP-4 inhibitor on daily glucose profile and coronary plaque character in diabetic patients with coronary artery disease
the IMpact of sitAgliptin on daily Glucose profIle and coroNary plaquE character in diabetic patients with coronary artery disease:IMAGINE-KOBE study
The impact of DPP-4 inhibitor on daily glucose profile and coronary plaque character in diabetic patients with coronary artery disease
the IMpact of sitAgliptin on daily Glucose profIle and coroNary plaquE character in diabetic patients with coronary artery disease:IMAGINE-KOBE study
Japan |
patients with coronary artery disease and type 2 diabetes
Medicine in general | Cardiology | Endocrinology and Metabolism |
Others
NO
Comparison of sitagliptine versus metformine on daily glucose profile analyzed by 24-hour continuous glucose monitoring system and coronary plaque character using coronary imaging devices in diabetic patients with coronary artery disease
Efficacy
Change in coronary plaque character analyzed by coronary angiography, intravascular ultrasound, and optical coherence tomography, and daily glucose profile analyzed by 24-hour continuous glucose monitoring system before and after 6 months treatment with sitagliptin in comparison with metformine
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Sitagliptin group:start with Sitagliptin 50 mg/day and up to 100 mg/day
Metformin group:Metformin 500 mg/day and up to 1000 mg/day
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1)In patients undergoing PCI, "untreated diabetes" and "HbA1c(NGSP) between 6.5 and 8.4, or FBS > 126mg/dl or casual blood glcose > 200mg/dl"
2)LDL-chol < 100mg/dl in patients without statin. LDL-chol < 120mg/dl in patients with statin.
3)patients between 20 and 75 years old
4)Written consent for participation in the study
Patients meeting one of the following conditions will be excluded:
1) poor control:HbA1c(NGSP)>8.5, or under treatment of diabetes, or type 1 diabetes
2)severe liver dysfunction
3)severe renal dysfunction (Cre 1.3 mg/dL)
4)severe heart failure) (NYHA/New York Heart Association stage III or severer)
5)Malignancies or other diseases with poor prognosis
6) pregnant, lactating, and possibly pregnant women and those planning to become pregnant
7) past medical history of hypersensitivity to investigational drugs
8) judged as ineligible by clinical investigators
44
1st name | Toshiro |
Middle name | |
Last name | Shinke |
Kobe University Graduate School of Medicine
Division of Cardiovascular Medicine
650-0017
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
078-382-5111
shinke@med.kobe-u.ac.jp
1st name | Hiroyuki |
Middle name | |
Last name | Yamamoto |
Kobe University Graduate School of Medicine
Division of Cardiovascular Medicine
650-0017
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, JAPAN
+81-78-382-5846
y0493589m@hotmail.co.jp
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Self funding
Division of diabetes and metabolism, Kobe University Graduate School of Medicine
Hyogo Brain and Heart Center
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
078-382-5846
y0493589m@hotmail.co.jp
NO
2012 | Year | 07 | Month | 04 | Day |
Unpublished
Completed
2012 | Year | 06 | Month | 25 | Day |
2012 | Year | 06 | Month | 25 | Day |
2012 | Year | 07 | Month | 01 | Day |
2019 | Year | 03 | Month | 30 | Day |
2019 | Year | 03 | Month | 30 | Day |
2012 | Year | 07 | Month | 04 | Day |
2022 | Year | 04 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009773
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