Unique ID issued by UMIN | UMIN000009544 |
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Receipt number | R000011201 |
Scientific Title | Comparison of efficacy of sitagliptin dose-up and that of glimepiride dose-up in Japanese subjects with type 2 diabetes inadequately controlled on combination therapy with sitagliptin and glimepiride |
Date of disclosure of the study information | 2013/03/31 |
Last modified on | 2012/12/14 09:10:03 |
Comparison of efficacy of sitagliptin dose-up and that of glimepiride dose-up in Japanese subjects with type 2 diabetes inadequately controlled on combination therapy with sitagliptin and glimepiride
sitagliptin and glimepiride randomized study
Comparison of efficacy of sitagliptin dose-up and that of glimepiride dose-up in Japanese subjects with type 2 diabetes inadequately controlled on combination therapy with sitagliptin and glimepiride
sitagliptin and glimepiride randomized study
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
It is unknown whether sitagliptin dose-up or glimepiride dose-up in combination therapy with sitagliptin and glimepiride is better on glycemic control in subjects with type 2 diabetes. The objective of the study was to compare the efficacy of these treatments in Japanese subjects with type 2 diabetes inadequately controlled on combination therapy with sitagliptin and glimepiride.
Efficacy
Confirmatory
Pragmatic
Not applicable
% change in HbA1c
% change in BMI, FPB and urinary 8-OHdG
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
+50 mg/day sitagliptin dose-up
+0.5 mg/day glimepiride dose-up
20 | years-old | <= |
Not applicable |
Male and Female
type 2 diabetes treated with sitagliptin (50 mg/day) in addition to glimepiride (<2.0 mg/day) with or without metformin at a stable dosage for at least 16 weeks, aged >20 years, HbA1c level >6.9%, and no improvement in HbA1c within 12 weeks
Subjects with type 1 diabetes, secondary diabetes, severe renal disease, severe hepatic disease, alcoholism, severe depression or severe psychological condition, malignancy or abnormal hemoglobinemia were excluded.
50
1st name | |
Middle name | |
Last name | Shinsuke Iwashita |
Kumamoto University
Department of Metabolic Medicine, Faculty of Life Sciences
1-1-1, Honjo Chuo-Ku, Kumamoto, 860-8556, Japan.
1st name | |
Middle name | |
Last name |
Kumamoto University
Department of Metabolic Medicine, Faculty of Life Sciences
1-1-1, Honjo Chuo-Ku, Kumamoto, 860-8556, Japan.
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
Self funding
NO
2013 | Year | 03 | Month | 31 | Day |
Unpublished
Open public recruiting
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 08 | Month | 01 | Day |
2013 | Year | 06 | Month | 30 | Day |
2013 | Year | 07 | Month | 30 | Day |
2012 | Year | 12 | Month | 14 | Day |
2012 | Year | 12 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011201
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