UMIN-CTR Clinical Trial

Basic information
Public title	Comparative efficacy and safety of antidiabetic drugs in treating diabetes mellitus
Acronym	Comparative efficacy and safety of antidiabetic drugs
Scientific Title	Comparative efficacy and safety of antidiabetic drugs in treating diabetes mellitus
Scientific Title:Acronym	Comparative efficacy and safety of antidiabetic drugs
Region	Japan Asia(except Japan) North America South America Australia Europe Africa

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

Objectives
Narrative objectives1	To assess comparative efficacy and safety of antidiabetic drugs in treating diabetes mellitus.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mortality, macrovascular event, microvascular event, dialysis, sepsis, diabetic ketoacidosis, amputation, fracture, and severe hypoglycemia
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	1 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	New user receiving or dispensed prescription of DPP-4 inhibitors, SGLT-2 inhibitors, and GLP-1 agonists, including fixed-dose combination (FDC) products containing these medication groups T2DM diagnosis on or prior to the index date
Key exclusion criteria	Patients with a T1DM diagnosis Patients with gestational diabetes within 1 year before index date
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Tomohide Middle name Last name Yamada
Organization	The University of Tokyo
Division name	Department of Diabetes and Metabolic Diseases
Zip code	1138655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-5841-2575
Email	YAMADAT-INT@h.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Tomohide Middle name Last name Yamada
Organization	The University of Tokyo
Division name	Health service center
Zip code	1138655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-5841-2575
Homepage URL
Email	YAMADAT-INT@h.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The University of Tokyo
Address	7-3-1, Hongo, Bunkyoku, Tokyo
Tel	1138655
Email	bqx07367@yahoo.co.jp

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	2018 Year 05 Month 09 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	Preinitiation
Date of protocol fixation	2018 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2020 Year 10 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The study will be conducted using anonymous data from claims, medical records and national health registries.

Management information
Registered date	2018 Year 05 Month 07 Day
Last modified on	2021 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037064