UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Reseach into the effects of sitagliptin on blood sugar control in patients with type2 diabetes
Title of the study (Brief title)	SPIRITS-J:Sitagliptin Registration Type2 Diabetes-Juntendo Collaborating Project
Region	Japan

Condition
Condition	Type2 Diabetes
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Reseach into the effects of sitagliptin on blood sugar control in patients with type 2 diabetes in Japanese
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of HbA1c levels after prescribing sitagliptin
Key secondary outcomes	the incidence of cardio-, cerebro-vascular events or diabetes-related complications

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	Patients with new onset or poorly controlled type 2 diabetes who are newly or additionally prescribed sitagliptin
Key exclusion criteria	1.Patients sufferd from severe ketosis, diabetic coma or semi-coma within 6-month before participating the study 2.Patients sufferd from severe infection or trauma, and perioperative 3.Possible or definitive pregnant women or nursing mother 4.Serum creatine levels are 1.5mg/dL or more 5.Patients with history of hypersensitivity to any ingredients of sitagliptin tablets 6.Other patients deemed not appropliate for participating to the study by investigators
Target sample size	3000

Research contact person
Name of lead principal investigator	Hiroyuki Daida
Organization	Juntendo University School of Medicine
Division name	Department of Cardiovascular Medicine
Address	2-1-1 Hongo Bunkyo-ku Tokyo, Japan
TEL	03-3813-3111
Email	daida@juntendo.ac.jp

Public contact
Name of contact person	Hirotoshi Ohmura
Organization	Juntendo University School of Medicine
Division name	Clinical Research Support Center
Address	3-1-1 Hongo Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL	http://www.juntendo.ac.jp/jcrc/index.html
Email	juntencrc@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine, Clinical Research Support Center
Institute
Department

Funding Source
Organization	Waksman Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	順天堂大学医学部臨床研究支援センター

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 12 Month 25 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date	2015 Year 09 Month 30 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 01 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	1.The efficacy of sitagliptin monotherapy 2.The efficacy of sitagliptin classificating by combination therapy 3.The incidence rate of adverse event by sitagliptin

Management information
Registered date	2010 Year 08 Month 28 Day
Last modified on	2017 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004320