Unique ID issued by UMIN | UMIN000028664 |
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Receipt number | R000032810 |
Scientific Title | Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM) - SPIKE Sub Study - |
Date of disclosure of the study information | 2017/08/15 |
Last modified on | 2018/02/16 17:39:29 |
Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM)
- SPIKE Sub Study -
Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM)
- SPIKE Sub Study -
Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM)
- SPIKE Sub Study -
Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM)
- SPIKE Sub Study -
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
The effects of glucose-lowering therapy with a DPP-4 inhibitor (Sitagliptin) on the progression of arteriosclerosis will be investigated in clinical cases based on comparison with a conventional treatment group without DPP-4 inhibitor treatment through analyses of existing data from "Study of Preventive Effects of Sitagliptin on Diabetic Atherosclerosis" (observation period completed, data fixed) in this study. A surrogate marker of cardiovascular events, the semi-quantitative index of carotid artery wall tissue characterization, gray-scale median (GSM) will be measured, and the inhibition of arteriosclerosis progression will be compared.
Efficacy
Amount of change in gray-scale median (GSM) during the 2-year observation period
Observational
30 | years-old | <= |
Not applicable |
Male and Female
Patients who meet all of the following criteria are included in this study.
1. Patients with type 2 diabetes (HbA1c [JDS value] of 6.6% or above) who do not show achievement of the target for glycemic control defined in the "Treatment Guide for Diabetes 2010" despite the three or more months of insulin therapy* (one to four injections per day during treatment with rapid-acting, ultra-rapid-acting, long-acting, intermediate-acting, or mixed insulin) or insulin therapy combined with oral diabetic agents other than DPP-4 inhibitors. Those who had previously used DPP-4 inhibitors but have not taken them for the recent twelve or more weeks are also included.
2. Patients aged 30 or older and younger than 80 years old (males and females)
3. Patients who have provided written consent to participate in the study
*Excluding CSII
Patients who fall into any of the following criteria are excluded from participating in the study.
1. Patients with type 1 or secondary diabetes
2. Patients with severe infections, pre-/post-operative status, or serious injuries
3. Patients with previous events of myocardial infarction, angina pectoris, stroke, or cerebral infarction
4. Patients complicated with diabetic retinopathy requiring retinal photocoagulation or crystalline lens surgery, or those who have undergone these treatments within the last one year
5. Patients with moderate or more severe renal dysfunction (serum creatinine [mg/dL] > 1.4 [male] or > 1.2 [female])
6. Patients with severe liver dysfunction (AST: 100 IU/l or above)
7. Patients with moderate or more severe heart failure (NYHA [New York Heart Association] class of III or above)
8. Patients who are prescribed with incretin-based agents, including other DPP-4 inhibitors at the time of commencement of the study
9. Patients taking diabetic medicines, etc., that are prohibited for combination with incretin-based agents including DPP-4 inhibitors, by health insurance, at the study initiation
10. Patients who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant
11. Patients with previous hypersensitivity to the investigated drug
12. Other patients determined ineligible by an investigator
274
1st name | |
Middle name | |
Last name | Naoto Katakami |
Osaka University Graduate School of Medicine
Department of Metabolic Medicine
2-2 Yamadaoka, Suita-shi, Osaka
06-6879-3732
katakami@endmet.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroki Takayama |
Soiken Inc.
Clinical Study Support Division
NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
03-3295-1350
takayama@soiken.com
Department of Metabolic Medicine, Osaka University Graduate School of Medicine
None
Self funding
NO
2017 | Year | 08 | Month | 15 | Day |
Unpublished
Completed
2016 | Year | 07 | Month | 05 | Day |
2016 | Year | 07 | Month | 05 | Day |
This is a retrospective study which analyzes the existing data of patients who were enrolled in the "Sitagliptin Prospective study of Intima media thickness Evaluation" (SPIKE study) UMIN000007396 starting on February 1st, 2012 (observation period has completed, data are fixed). Data are evaluated for the treatment effectiveness of sitagliptin to suppress the progression of diabetic atherosclerosis.
2017 | Year | 08 | Month | 15 | Day |
2018 | Year | 02 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032810
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