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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005994
Receipt No. 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

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Basic information
Public title Efficacy and safety of sitagliptin in patients with type 2 diabetes: a multicentre observational study
Acronym BIRIKEN-2 Study (Blood glucose Investigation and Reduction In Kansai area by ENdocrinologist-2 Study)
Scientific Title Efficacy and safety of sitagliptin in patients with type 2 diabetes: a multicentre observational study
Scientific Title:Acronym BIRIKEN-2 Study (Blood glucose Investigation and Reduction In Kansai area by ENdocrinologist-2 Study)
Region
Japan

Condition
Condition Diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in HbA1c after 3 months from baseline
Key secondary outcomes 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.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruo Nishimura
Organization Osaka Saiseikai Nakatsu Hospital
Division name Division of diabetes and endocrinology
Zip code
Address 2-10-39, Shibata, Kita-ku, Osaka-city
TEL 06-6372-0333
Email hnis@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruo Nishimura
Organization Osaka Saiseikai Nakatsu Hospital
Division name Division of diabetes and endocrinology
Zip code
Address 2-10-39, Shibata, Kita-ku, Osaka-city
TEL 06-6372-0333
Homepage URL
Email 23001@nakatsu.saiseikai.or.jp

Sponsor
Institute Association for future management of diabetes
Institute
Department

Funding Source
Organization Research foundation for community medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Association for future management of diabetes
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
2015 Year 01 Month 01 Day
Date trial data considered complete
2015 Year 02 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information 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.

Management information
Registered date
2011 Year 07 Month 18 Day
Last modified on
2016 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007091

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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