Unique ID issued by UMIN | UMIN000005460 |
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Receipt number | R000006475 |
Scientific Title | Efficacy of Sitagliptin on glycaemic control in drug naïve patients with type 2 diabetes (STRICT-2) |
Date of disclosure of the study information | 2011/04/18 |
Last modified on | 2018/03/07 14:44:15 |
Efficacy of Sitagliptin on glycaemic control in drug naïve patients with type 2 diabetes (STRICT-2)
SiTagliptin Randomized Intervention Clinical Trial - 2(STRICT-2)
Efficacy of Sitagliptin on glycaemic control in drug naïve patients with type 2 diabetes (STRICT-2)
SiTagliptin Randomized Intervention Clinical Trial - 2(STRICT-2)
Japan |
Type 2 Diabetes Mellitus
Endocrinology and Metabolism |
Others
NO
To investigate and compare the efficacy of sitagliptin on glycaemic control with glinides and metformin
Safety,Efficacy
Exploratory
Pragmatic
Phase IV
Changes of HbA1c from baseline
Fasted plasma glucose, Fasted serum insulin, Compliance of treatment, Adverse effects
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
3
Treatment
Medicine |
Sitagliptin treatment, 3 months
Glinides treatment, 3 months
Metformin treatment, 3 months
20 | years-old | <= |
81 | years-old | > |
Male and Female
Drug naïve patients with type 2 diabetes who are poorly glycaemic controlled by lifestyle intervention.
HbA1c: >6.5%, <9.0%
1.Contraindication for sitagliptin
2.Contraindication for glinides
3.Contraindication for metformin
4.Patients treated with insulin
5.Pregnant or possible pregnant
6.Patients with sever liver failure or renal failure
7.Patients considered not eligible for the study by the attending doctor due to other reasons
300
1st name | |
Middle name | |
Last name | Eiichi Araki |
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
1-1-1 Honjo, Kumamoto, 860-8556, Japan
096-373-5169
1st name | |
Middle name | |
Last name | Kayo Takeda |
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
1-1-1 Honjo, Kumamoto, 860-8556, Japan
096-373-5169
STRICT study Group
Public Health Research Foundation
Non profit foundation
Japan
NO
熊本大学医学部附属病院(熊本県),九州大学病院(福岡県),久留米大学病院(福岡県),産業医科大学病院(福岡県),佐賀大学医学部附属病院(佐賀県),長崎大学病院(長崎県),大分大学医学部附属病院(大分県),宮崎大学医学部附属病院(宮崎県),鹿児島大学病院(鹿児島県),琉球大学医学部附属病院(沖縄県)
2011 | Year | 04 | Month | 18 | Day |
Unpublished
Completed
2011 | Year | 01 | Month | 20 | Day |
2011 | Year | 03 | Month | 01 | Day |
2013 | Year | 08 | Month | 31 | Day |
2011 | Year | 04 | Month | 18 | Day |
2018 | Year | 03 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006475
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