Unique ID issued by UMIN | UMIN000005178 |
---|---|
Receipt number | R000006150 |
Scientific Title | Efficacy of Sitagliptin added to sulfonylurea in subjects with poorly controlled type 2 diabetes (STRICT-1) |
Date of disclosure of the study information | 2011/03/09 |
Last modified on | 2018/03/07 14:43:44 |
Efficacy of Sitagliptin added to sulfonylurea in subjects with poorly controlled type 2 diabetes (STRICT-1)
SiTagliptin Randomized Intervention Clinical Trial- 1(STRICT-1)
Efficacy of Sitagliptin added to sulfonylurea in subjects with poorly controlled type 2 diabetes (STRICT-1)
SiTagliptin Randomized Intervention Clinical Trial- 1(STRICT-1)
Japan |
Type 2 Diabetes Mellitus
Endocrinology and Metabolism |
Others
NO
To investigate and compare the efficacy of sitagliptin on glycaemic control and pancreatic beta-cell function with alpha-glucosidase inhibitor in poorly controlled type 2 diabetes subjects with sulfonylurea
Safety,Efficacy
Exploratory
Pragmatic
Phase IV
Changes of HbA1c from baseline
Fasted plasma glucose, Fasted serum insulin, Proinsulin-insulin ratio, and glucagon-induced CPR (changes from each baseline)
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
2
Treatment
Medicine |
Sitagliptin treatment, 6 months
alpha-glucosidase inhibitor treatment, 6 months
20 | years-old | <= |
81 | years-old | > |
Male and Female
Type 2 diabetes patients with poorly glycaemic control by sulfonylurea therapy
In this study, we defined "poorly glycaemic control by sulfonylurea" as bellow.
Dose of sulfonylurea: Recommemded doses by the Committee for "Reasonable use of GLP-1 analogues and DPP-4 inhibitors"
Duration of sulfonylurea: current dose for over 3 months
HbA1c keeps
1. 6.5% or more than 6.5%
2. Once below 6.5%, exceed 6.5% again
in current 3 months' observation.
HbA1c in the registration is within 6.5-8.5%
Concomitant oral antidiabetic drugs: TZDs or BGs are eligible
1.Contraindication for sitagliptin
2.Contraindication for alpha-glucosidase inhibitors
3.Patients treated with insulin
4.Pregnant or possible pregnant
5.Patients with severe liver failure or renal failure
6.Patients considered not eligible for the study by the attending doctor due to other reasons
7.Patients with past history of treatment of sitagliptin or other incretin related drugs
200
1st name | |
Middle name | |
Last name | Eiichi Araki |
Department of Metabolic Medicine, Faculty of Life Science, Kumamoto University
Department of Metabolic Medicine, Faculty of Life Science, Kumamoto University
1-1-1 Honjo, Kumamoto, 860-8556, Japan
096-373-5169
asano@phrf.jp
1st name | |
Middle name | |
Last name | Junji Kawashima |
Department of Metabolic Medicine, Faculty of Life Science, Kumamoto University
Department of Metabolic Medicine, Faculty of Life Science, Kumamoto University
1-1-1 Honjo, Kumamoto, 860-8556, Japan
096-373-5169
jkawashima@fc.kuh.kumamoto-u.ac.jp
STRICT study Group
Public Health Research Foundation
Non profit foundation
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),琉球大学医学部附属病院(沖縄県)
2011 | Year | 03 | Month | 09 | Day |
Unpublished
Completed
2011 | Year | 01 | Month | 20 | Day |
2011 | Year | 03 | Month | 01 | Day |
2013 | Year | 11 | Month | 30 | Day |
2011 | Year | 03 | Month | 03 | Day |
2018 | Year | 03 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006150
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |