UMIN-CTR Clinical Trial

Basic information
Public title	Effects of anagliptin/metformin combination tablets: a retrospective observational study
Acronym	Effects of anagliptin/metformin combination tablets: a retrospective observational study
Scientific Title	Effects of anagliptin / metformin hydrochloride combination tablets in patients with type 2 diabetes: a retrospective observational study
Scientific Title:Acronym	Effects of anagliptin / metformin hydrochloride combination tablets in patients with type 2 diabetes: a retrospective observational study
Region	Japan

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

Objectives
Narrative objectives1	This study aims to evaluate the effects of anagliptin / metformin hydrochloride combination tablets in patients with type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in HbA1c
Key secondary outcomes	1.Change in LDL-C 2.Change in HDL-C 3.Change in eGFR 4.Change in body weight, BMI and body composition 5.Incidence of adverse events

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with type 2 diabetes 2. Patients who started receiving of anagliptin / metformin hydrochloride combination tablets from November 21st, 2018 to May 31st, 2020 (data collection period) and continued for more than 12 weeks
Key exclusion criteria	1. Patients who received antidiabetic drugs for less than 8 weeks before switch to anagliptin / metformin hydrochloride combination tablets 2. Patients who denied the use of clinical medical records to the study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Fukuda
Organization	Fukuda Clinic
Division name	Internal Medicine
Zip code	532-0003
Address	2F Shin-Osaka Brick Building, 1-6-1, Miyahara, Yodogawa-ku, Osaka-shi, Osaka Japan
TEL	06-6398-0203
Email	fukuda@drmog.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Fukuda
Organization	Fukuda Clinic
Division name	Internal Medicine
Zip code	532-0003
Address	2F Shin-Osaka Brick Building, 1-6-1, Miyahara, Yodogawa-ku, Osaka-shi, Osaka Japan
TEL	06-6398-0203
Homepage URL	https://dmclinic.jp
Email	fukuda@drmog.jp

Sponsor
Institute	Fukuda Clinic
Institute
Department

Funding Source
Organization	SANWA KAGAKU KENKYUSHO CO.,LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Japan Physicians Association Institutional Review Board
Address	Tokyo Medical Association Building 4F, 2-5, Kanda-Surugadai, Chiyoda, Tokyo, 101-0062, Japan
Tel	03-3259-6177
Email	irb@nichirinnai.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	2020 Year 10 Month 02 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	90
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	No longer recruiting
Date of protocol fixation	2020 Year 06 Month 02 Day
Date of IRB	2020 Year 07 Month 29 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study retrospectively collects the medical records in patients with type 2 diabetes who received anagliptin / metformin hydrochloride combination tablets in Fukuda Clinic, and evaluates the clinical outcomes.

Management information
Registered date	2020 Year 10 Month 02 Day
Last modified on	2020 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047914

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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