Unique ID issued by UMIN | UMIN000004674 |
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Receipt number | R000005463 |
Scientific Title | Examine the comparative availability of DPP-4 Inhibitor versus Alfa-glycosidase inhibitor for the type 2 diabetic patient who was treated with Sulfonylurea |
Date of disclosure of the study information | 2010/12/07 |
Last modified on | 2013/06/29 22:58:49 |
Examine the comparative availability of DPP-4 Inhibitor versus Alfa-glycosidase inhibitor for the type 2 diabetic patient who was treated with Sulfonylurea
Study for an ultimate combination therapy to control diabetes with Sitagliptin-2
Examine the comparative availability of DPP-4 Inhibitor versus Alfa-glycosidase inhibitor for the type 2 diabetic patient who was treated with Sulfonylurea
Study for an ultimate combination therapy to control diabetes with Sitagliptin-2
Japan |
Type 2 Diabetes Mellitus
Endocrinology and Metabolism |
Others
NO
Examine the comparative availability of DPP-4 Inhibitor, Sitagliptin versus Alfa-glycosidase inhibitor for the type 2 diabetic patient who responded suboptimal glycemic control with Sulfonylurea alone.
Others
Examine the clinical availability on Sitagliptin by comparing the lipid metabolism, oxidative-stress marker and tolerability.
Confirmatory
Pragmatic
Change of HbA1c from the baseline to 12 weeks later
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Sulfonylurea (glimepiride) + Stagliptin
Sulfonylurea (glimepiride) + Alpha-Glycosidase inhibitor
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Patients with type 2 diabetes
2)Patients with suboptimal glycemic control by glimepiride 2mg/day for more than 2 months treatments.
3)Age >=20 years, <80 years (Male and Female)
4)A consent form for participating in this study is submitted
1)Patients with type 1 diabetes
2)History of severe ketosis, diabetic coma or precoma within 6 months
3)Patients with severe infections, before or after operation, or with serious trauma
4)Patients with exceeding the moderate renal impairment
5)Patients with history of stroke, MI or other sever vascular complication which required a hospitalization within six months.
6)Patients receiving DPP-4 Inhibitor except Sitagliptin
7)Patients receiving Alfa-glycosidase inhibitor, Sulfonylurea or Glinide during obtaining the informed consent or received Insulin treatment in the past 2 months.
Patients receiving alfa-glucosidase inhibitor or suruhoniyl urea or glinide at getting the informed consent or recieving Insulin within 2 months
8)Patients receiving glimepiride more than 2mg/day at getting the informed concent
9)Patients who are pregnant, breastfeeding or intention to becoming pregnant
10)Having allergy to DPP-4 Inhibitor or alfa-glucosidase inhibitor
11)Other patients determined to be inappropriate by physician
114
1st name | |
Middle name | |
Last name | Kotaro Yokote |
Graduate School of Medicine, Chiba University
Clinical Cell Biology and Medicine
1-8-1 Inohana, Chuo-ku, 260-8670, Chiba-city
1st name | |
Middle name | |
Last name |
Graduate School of Medicine, Chiba University
Clinical Cell Biology and Medicine
1-8-1 Inohana, Chuo-ku, 260-8670, Chiba-city
Graduate School of Medicine, Chiba University
Waksman Financial Group
Non profit foundation
NO
2010 | Year | 12 | Month | 07 | Day |
Unpublished
Completed
2010 | Year | 11 | Month | 17 | Day |
2011 | Year | 01 | Month | 01 | Day |
2012 | Year | 08 | Month | 10 | Day |
2012 | Year | 10 | Month | 14 | Day |
2010 | Year | 12 | Month | 07 | Day |
2013 | Year | 06 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005463
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