Unique ID issued by UMIN | UMIN000009950 |
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Receipt number | R000011615 |
Scientific Title | Effect of Sitagliptin And Miglitol on Insulin Therapy in patients with type 2 diabetes |
Date of disclosure of the study information | 2013/03/01 |
Last modified on | 2016/02/23 10:48:58 |
Effect of Sitagliptin And Miglitol on Insulin Therapy in patients with type 2 diabetes
SAMIT study
Effect of Sitagliptin And Miglitol on Insulin Therapy in patients with type 2 diabetes
SAMIT study
Japan |
type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
Comparison of effect of sitagliptin and miglitol on insulin therapy in patients with type 2 diabetes
Efficacy
Exploratory
Glycemic control and glycemic excursion(variation,mean amplitude of glycemic excursion,24 hour blood glucose AUC, 1- and 2-hour postprandial glucose level by CGMS)
plasma glucose, serum CPR, actived GLP-1, total GIP and glucagon after diet challenge test
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
sitagliptin50mg/day
Sitagliptin50mg/day+miglitol150mg/day
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Inpatients with type 2 diabetes
2)fasting plasma glucose from 80 to 140mg/dl using by insulin glargine
3)more than 2 hr postprandial glucose levels 180mg/dl
4)Age>=20
1)type1 diabetes, 2)severe hepatic dysfunction(AST>100mg/dl,ALT>100mg/dl), 3)severe renal dysfunction(sCr>=2.0mg/dl), 4)past history of abdominal surgery, 5)histry of anaphylaxis of DPP-4 inhibitor and arufa-glucosidase inhibitor, 6)pregnant, intention of becoming pregnant, 7)poor plasma glocose control, 8)Any other condition which the attending physician feels would interfere with the trail participation,
9)steroid treatment or steroid diabetes.
30
1st name | |
Middle name | |
Last name | Ryo Kodera |
Okayama University Hospital
Center for Innovative Clinical Medicine
2-5-1 Shikata-cho, Kita-ku, Okayama
086-235-6510
kodera@cc.okayama-u.ac.jp
1st name | |
Middle name | |
Last name | Ryo Kodera |
Okayama University Hospital
Center for Innovative Clinical Medicine
2-5-1 Shikata-cho, Kita-ku, Okayama
086-235-6510
kodera@cc.okayama-u.ac.jp
Okayama University Hospital
Sanwa kagaku kenkyusho Co.,LTD.
Profit organization
Japan
NO
2013 | Year | 03 | Month | 01 | Day |
Unpublished
Terminated
2013 | Year | 01 | Month | 18 | Day |
2013 | Year | 03 | Month | 01 | Day |
2016 | Year | 02 | Month | 23 | Day |
2016 | Year | 02 | Month | 23 | Day |
2013 | Year | 02 | Month | 04 | Day |
2016 | Year | 02 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011615
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