Unique ID issued by UMIN | UMIN000005994 |
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Receipt number | R000007091 |
Scientific Title | Efficacy and safety of sitagliptin in patients with type 2 diabetes: a multicentre observational study |
Date of disclosure of the study information | 2011/07/18 |
Last modified on | 2016/12/12 11:39:25 |
Efficacy and safety of sitagliptin in patients with type 2 diabetes: a multicentre observational study
BIRIKEN-2 Study (Blood glucose Investigation and Reduction In Kansai area by ENdocrinologist-2 Study)
Efficacy and safety of sitagliptin in patients with type 2 diabetes: a multicentre observational study
BIRIKEN-2 Study (Blood glucose Investigation and Reduction In Kansai area by ENdocrinologist-2 Study)
Japan |
Diabetes mellitus
Endocrinology and Metabolism |
Others
NO
The study aims to evaluate efficacy and safety of a DDP-4 inhibitor, sitagliptin, in patients with type 2 diabetes. In addition, stratified analyses by treatment (monotherapy vs combination therapy), and patient background will be conducted to identify patients who can benefit from treatment with sitagliptin.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Changes in HbA1c after 3 months from baseline
1) Changes and %changes in HbA1c after 3, 6, 12, 18 and 24 months from baseline in the following parameters (excluding the value after 3 months): Fasting blood glucose or postprandial blood glucose (optional) and body weight.
2) Exploratory analyses
Stratified analyses by treatment (monotherapy vs combination therapy) and patient background (sex, baseline values, length of diabetes, BMI) etc. to identify patients who can benefit from glucose-lowering treatment with sitagliptin.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with type 2 diabetes who had received diet and exercise therapy or treatment with antidiabetic agents other than a DPP-4 inhibitor in addition to diet and exercise therapy for more than 1 month, and whose blood glucose has not been sufficiently controlled*.
2) Outpatients aged 20 years and above,, male and female.
3) Patients who have given written consent for the study
Patients who meet any of the following criteria will be excluded from the study.
1) Patients with type 1 diabetes
2) Patients who had a history of severe ketosis, diabetic coma or complete coma within previous 6 months
3) Patients before or after operation, and those with severe infections or serious injury
4) Patients with severe kidney dysfunction
5) Patients who had severe cardiovascular complications that require hospitalization within 6 months before signing the informed consent
6) Patients who are pregnant or maybe can pregnant and patients are lactating.
7) Patients with a history of hypersensitivity to the study drug
8) Patients who are considered not eligible for the study by the attending doctor due to other reasons
500
1st name | |
Middle name | |
Last name | Haruo Nishimura |
Osaka Saiseikai Nakatsu Hospital
Division of diabetes and endocrinology
2-10-39, Shibata, Kita-ku, Osaka-city
06-6372-0333
hnis@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Haruo Nishimura |
Osaka Saiseikai Nakatsu Hospital
Division of diabetes and endocrinology
2-10-39, Shibata, Kita-ku, Osaka-city
06-6372-0333
23001@nakatsu.saiseikai.or.jp
Association for future management of diabetes
Research foundation for community medicine
Non profit foundation
Japan
Association for future management of diabetes
NO
大阪府済生会中津病院(大阪府)、大阪府済生会茨木病院(大阪府)、馬場内科クリニック(大阪府)、市立岸和田市民病院(大阪府)、大歳内科(大阪府)、医仁会武田総合病院(京都府)、今村クリニック(大阪府)、大阪赤十字病院(大阪府)、大阪市立十三市民病院(大阪府)、大阪府立急性期・総合医療センター(大阪府)、大橋クリニック(大阪府)、奥田内科クリニック(大阪府)、近畿大学医学部奈良病院(奈良県)、神戸市立医療センター中央市民病院(兵庫県)、十条リハビリテーション病院(京都府)、センプククリニック(大阪府)、ふくだ内科クリニック(大阪府)
2011 | Year | 07 | Month | 18 | Day |
Unpublished
Completed
2010 | Year | 06 | Month | 15 | Day |
2010 | Year | 07 | Month | 01 | Day |
2014 | Year | 12 | Month | 01 | Day |
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 02 | Month | 01 | Day |
2015 | Year | 03 | Month | 01 | Day |
1) Changes and %changes in HbA1c after 3, 6, 12, 18 and 24 months from baseline in the following parameters (excluding the value after 3 months): Fasting blood glucose or postprandial blood glucose (optional) and body weight.
2) Exploratory analyses
Stratified analyses by treatment (monotherapy vs combination therapy) and patient background (sex, baseline values, length of diabetes, BMI) etc. to identify patients who can benefit from glucose-lowering treatment with sitagliptin.
2011 | Year | 07 | Month | 18 | Day |
2016 | Year | 12 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007091
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