UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Vascular event risks of DPP-4 inhibitors in Japanese patients with type 2 diabetes: a comparative effectiveness study using a large scale hospital database
Title of the study (Brief title)	Vascular risks of DPP-4 inhibitors
Region	Japan

Condition
Condition	Type 2 Diabetes
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Estimation of cardio/cerebrovascular risks of DPP-4 inhibitors in Japanese patients with tyep 2 diabetes using a large-scale Japanese hospital database including administrative and laboratory data.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Composite endpoint including cardiac infarction, cerebral infarction, and cerebral hemorrhage.
Key secondary outcomes	individual vascular events including cardiac infarction, cerebral infarction, and cerebral hemorrhage.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Having diagnosis codes for type 2 diabetes (ICD-10 E11, E12, E13, and E14) 2. New users of anti-diabetic medicines
Key exclusion criteria	2. Having diagnosis code of ICD-10 E10 for type 1 diabetes
Target sample size	100000

Research contact person
Name of lead principal investigator	Hisashi Urushihara
Organization	Keio University
Division name	Drug Development and Regulatory Science, Faculty of Pharmacy
Address	1-5-30, Shiba-Koen, Minato-Ku, Tokyo
TEL	03-5400-2649
Email	urushihara-hs@pha.keio.ac.jp

Public contact
Name of contact person	Hisashi Urushihara
Organization	Keio University
Division name	Drug Development and Regulatory Science, Faculty of Pharmacy
Address	1-5-30, Shiba-Koen, Minato-Ku, Tokyo
TEL	03-5400-2649
Homepage URL
Email	urushihara-hs@pha.keio.ac.jp

Sponsor
Institute	Drug Development and Regulatory Science, Faculty of Pharmacy Keio University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Keio University
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 17 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2015 Year 02 Month 01 Day
Date of closure to data entry	2015 Year 02 Month 18 Day
Date trial data considered complete	2015 Year 02 Month 28 Day
Date analysis concluded	2015 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Retrospective cohort analysis using the EBM provider, a hospital information database covering administrative, and diagnosis-procedure combination data and laboratory data from 147 secondary medical care hospitals, totaling more than 7.5 million patients. DPP-4 inhibitor group and other diabetic medication group excluding SGLT-2 and insulin were compared.

Management information
Registered date	2014 Year 10 Month 07 Day
Last modified on	2016 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017868