Unique ID issued by UMIN | UMIN000003951 |
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Receipt number | R000004758 |
Scientific Title | Effect of a DPP-4 inhibitor or an alpha-glucosidase inhibitor on endothelial function in patients with type 2 diabetes |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2014/08/31 15:20:48 |
Effect of a DPP-4 inhibitor or an alpha-glucosidase inhibitor on endothelial function in patients with type 2 diabetes
Effect of a DPP-4 inhibitor on endothelial function (EDGE)
Effect of a DPP-4 inhibitor or an alpha-glucosidase inhibitor on endothelial function in patients with type 2 diabetes
Effect of a DPP-4 inhibitor on endothelial function (EDGE)
Japan |
Type 2 diabetic patients
Cardiology |
Others
NO
To compare the effects of a DPP-4 inhibitor, sitagliptin, and an alpha-glucosidase inhibitor, voglibose, on endothelial function in patients with type 2 diabetes
Efficacy
% FMD after 12 weeks
Change and % change in the following values in the 2 groups at 12 weeks after the initiation of treatment
FPG
HbA1c
Incretin concentration (GIP, GLP-1)
Endogenous insulin / glucagon
C-peptide
Lipid profile (TC, HDL-C, TG)
Adiponectin
CD34
hs-CRP
PTX-3
MDA-LDL
Urine-OHDG
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
DPP-4 inhibitor
alpha-glucosidase inhibitor
20 | years-old | <= |
85 | years-old | > |
Male and Female
1, T2DM patients those who have been treated with the diabetic therapy and whose blood glucose has not been sufficiently controlled
2, Obtaining written informed consent
1, The patient under insulin treatment
2, The patient under alpha-GI or Gulinide treatment
3, Type 1 diabetes mellitus
4, Insufficiently controlled diabetes mellitus (HbA1c >= 9.0% )
5, Insufficiently controlled hypertension (SBP>=160mmHg)
6, Severe ketosis, diabetic coma, or precoma within the past six months
7, Severe infectious disease, pre/ post operation or serious injury
8, Women who are pregnant, possibly pregnant, or are breastfeeding
9, Mild renal dysfunction (sCr>=1.5 mg/dl)
10, Hypersensitivity or allergy to sitagliptin and voglibose
11, Patients who are determined by the investigators to be unsuitable
50
1st name | |
Middle name | |
Last name | Hiroshi Ito |
Okayama University Medical School
Department of Cardiovascular Medicine
2-5-1 Shikada-cho Kita-ku Okayama
1st name | |
Middle name | |
Last name |
Cardiovascular Dysfunction Study group
Research Secretariat Office
03-3814-1616
Cardiovascular Dysfunction Study group
Osaka Prevention Institute for Cancer and Cardiovascular Diseases Foundation
Non profit foundation
Japan
NO
2010 | Year | 10 | Month | 01 | Day |
Published
Completed
2010 | Year | 07 | Month | 20 | Day |
2010 | Year | 10 | Month | 01 | Day |
Nakamura K et al.: Cardiovascular Diabetology 2014, 13:110
2010 | Year | 07 | Month | 26 | Day |
2014 | Year | 08 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004758
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