Unique ID issued by UMIN | UMIN000004985 |
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Receipt number | R000005919 |
Scientific Title | The effect of sitagliptin on pancreatic beta-cell protection for the type 2 diabetic patients treated with sulfonylurea : a prospective randomized, multicenter, open-label, comparative study. |
Date of disclosure of the study information | 2011/02/01 |
Last modified on | 2011/01/31 14:54:58 |
The effect of sitagliptin on pancreatic beta-cell protection for the type 2 diabetic patients treated with sulfonylurea : a prospective randomized, multicenter, open-label, comparative study.
Sitagliptin vs. Step-up SU Study for the protection of beta-cell in Shinshu (SSSSS)
The effect of sitagliptin on pancreatic beta-cell protection for the type 2 diabetic patients treated with sulfonylurea : a prospective randomized, multicenter, open-label, comparative study.
Sitagliptin vs. Step-up SU Study for the protection of beta-cell in Shinshu (SSSSS)
Japan |
Type 2 Diabetes Mellitus
Endocrinology and Metabolism |
Others
NO
To compare the effect of sulfonylurea uptitration versus add-on sitagliptin on pancreatic beta-cell protection for type 2 diabetic patient inadequately controlled by sulfonylurea.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
Pancreatic beta-cell protection ( Serum C peptide, Intact proinsulin/Insulin ratio )
HbA1c, fasting plasma glucose, HOMA-beta, Insulinogenic Index, Total cholesterol, triglyceride, HDL cholesterol, BNP, cystatin C, urinary albumin/creatinin ratio, body weight, adherence
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Titration of Glimepiride
Add-on Stagliptin
20 | years-old | <= |
75 | years-old | > |
Male and Female
1. Patients with type 2 diabetes who is treated by Glimepiride less than 2mg/day for more than 4 weeks.
2. Age >= 20 years, <75 years, Male and Female
3. HbA1c >= 7.0%, <9.0% JDS
1. Patients with renal failure.
2. Patients with cancer.
3. Patients with nephropathy more than 3b period.
4. Patients with preproliferative or proliferative retinopathy.
5. Other patients determined to be inappropriate by physician.
240
1st name | |
Middle name | |
Last name | Mitsuhisa Komatsu |
Shinshu University Graduate School, Devision of Medicine
Department of Aging Medicine and Geriatrics
3-1-1 Asahi, Matsumoto-city, Nagano, 390-8621 JAPAN
0263-37-2686
1st name | |
Middle name | |
Last name | Teiji Takeda |
Shinshu University Graduate School, Devision of Medicine
Department of Aging Medicine and Geriatrics
3-1-1 Asahi, Matsumoto-city, Nagano, 390-8621 JAPAN
0263-37-2686
Shinshu University Graduate School, Devision of Medicine, Department of Aging Medicine and Geriatrics
The society for diabetes of Japanese
Other
Japan
NO
信州大学医学部附属病院(長野県)、小諸厚生病院(長野県)、岡谷市民病院(長野県)、千曲中央病院(長野県)、飯田市立病院(長野県)、長野市民病院(長野県)、国保浅間総合病院(長野県)、長野中央病院(長野県)、松本医療センター(長野県)、諏訪赤十字病院(長野県)、富士見高原病院(長野県)、篠ノ井総合病院(長野県)、伊那中央病院(長野県)、市立波田病院(長野県)
2011 | Year | 02 | Month | 01 | Day |
Unpublished
Preinitiation
2011 | Year | 01 | Month | 21 | Day |
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 01 | Month | 31 | Day |
2011 | Year | 01 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005919
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