UMIN-CTR Clinical Trial

Basic information
Public title	Effect of switch from EquMet combination tablet to METOANA combination tablet
Acronym	Effect of switch from EquMet combination tablet to METOANA combination tablet
Scientific Title	Effect of switch from metformin / vildagliptin fixed-dose combination tablet to metformin / anagliptin fixed-dose combination tablet
Scientific Title:Acronym	Effect of switch from metformin / vildagliptin fixed-dose combination tablet to metformin / anagliptin fixed-dose combination tablet
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 clinical outcomes of biguanide / DPP-4 inhibitor fixed-dose combination tablet effect by comparing the patients who switched from metformin / vildagliptin fixed-dose combination tablet to metformin / anagliptin fixed-dose combination tablet with the patients who continued metformin / vildagliptin fixed-dose combination tablet. The clinical outcomes are also estimated stratified by renal function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Time-dependent change in HbA1c in switch group and non-switch group
Key secondary outcomes

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 mellitus 2. Male and female aged of 20 years or older 3. Patients who switched from metformin / vildagliptin fixed-dose combination tablet (twice daily) to metformin / anagliptin fixed-dose combination tablet (twice daily) in Kurihara Clinic of Internal Medicine between November 21st, 2018 and March 31st, 2019, and continued visiting the clinic for 6 months or longer (switch group) 4. Patients who continued metformin / vildagliptin fixed-dose combination tablet (twice daily) after the first test between November 21st, 2018 and March 31st, 2019, and continued visiting Kurihara Clinic of Internal Medicine for 6 months or longer (non-switch group) 5. Patients who continued metformin / vildagliptin fixed-dose combination tablet (twice daily) for 3 months or longer before the switch to metformin / anagliptin fixed-dose combination tablet in switch group or before the first test in non-switch group
Key exclusion criteria	1. Patients who are treated by combination of metformin / vildagliptin fixed-dose combination tablet LD and HD 2. Patients who changed the dose of metformin / vildagliptin fixed-dose combination tablet during the metformin / vildagliptin fixed-dose combination tablet administration period 3. Patients who changed the dose of metformin / anagliptin fixed-dose combination tablet during the metformin / anagliptin fixed-dose combination tablet administration period 4. Patients who changed the type or dose of hypoglycemic agents or antihyperlipidemic agents 5. Patients who are treated by dialysis or patients with severe renal impairment (eGFR < 30 mL/min/1.73m2) at baseline 6. Female patients who are pregnant, breastfeeding, possibly pregnant, or planning to become pregnant 7. Patients who denied the use of clinical medical records to the study 8. Patients with any conditions that physicians thought to be inappropriate to participate in the study such as poor adherence
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Yoshio Middle name Last name Kurihara
Organization	Kurihara Clinic of Internal Medicine
Division name	Internal Medicine
Zip code	004-0053
Address	7-28,3-jo 5-chome, Atsubetsu-Chuo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL	0118923522
Email	ykuri@yg7.so-net.ne.jp

Public contact
Name of contact person	1st name Yoshio Middle name Last name Kurihara
Organization	Kurihara Clinic of Internal Medicine
Division name	Internal Medicine
Zip code	004-0053
Address	7-28,3-jo 5-chome, Atsubetsu-Chuo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL	0118923522
Homepage URL
Email	ykuri@yg7.so-net.ne.jp

Sponsor
Institute	Kurihara Clinic of Internal Medicine
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	Kyoyukai RiverSide Clinic
Address	2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel	011-521-2321
Email	rinrishinsa@riversideclinic.or.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 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://lifescience.co.jp/tr/21/tr2101.html
Number of participants that the trial has enrolled	142
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 01 Month 30 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 12 Month 13 Day
Date of IRB	2020 Year 01 Month 28 Day
Anticipated trial start date	2020 Year 02 Month 01 Day
Last follow-up date	2020 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 06 Month 30 Day
Date analysis concluded	2020 Year 07 Month 21 Day

Other
Other related information	none

Management information
Registered date	2020 Year 06 Month 30 Day
Last modified on	2021 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046777