UMIN-CTR Clinical Trial

Basic information
Public title	Variable effects of diabetes-related medications on SGLT2-induced eGFR changes in diabetic patients
Acronym	SGLT2-induced eGFR changes in diabetic patients
Scientific Title	Variable effects of diabetes-related medications on SGLT2-induced eGFR changes in diabetic patients
Scientific Title:Acronym	SGLT2-induced eGFR changes in diabetic patients
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify variable effects of diabetes-related medications on SGLT2-induced eGFR changes in diabetic patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The changes in eGFR over one year in diabetic patients using combination drugs given SGLT2 inhibitors
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Men and women who were diagnosed with diabetes mellitus taking SGLT-2 inhibitor
Key exclusion criteria	Patients who fall under any of HbA1c> 11.0, use of steroids, use of immunosuppressant, use of NSAID, or other acute disease
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Toshihiko Middle name Last name Suzuki
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Division name	Department of Nephrology, Endocrinology and Diabetes
Zip code	2790001
Address	3-4-32 Todaijima, Urayasu, Chiba, Japan
TEL	0473513101
Email	toshi-s@xj9.so-net.ne.jp

Public contact
Name of contact person	1st name Koichi Middle name Last name Kitamura
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Division name	Department of Nephrology, Endocrinology and Diabetes
Zip code	2790001
Address	3-4-32 Todaijima, Urayasu, Chiba, Japan
TEL	0473513101
Homepage URL
Email	japan.koichi@gmail.com

Sponsor
Institute	Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department

Funding Source
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
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	Tokyo Bay Urayasu Ichikawa Medical Center
Address	3-4-32 Todaijima, Urayasu, Chiba, Japan
Tel	0473513101
Email	toshi-s@xj9.so-net.ne.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	2019 Year 06 Month 13 Day

Related information
URL releasing protocol	https://www.nature.com/articles/s41440-020-00590-1
Publication of results	Published

Result
URL related to results and publications	https://www.nature.com/articles/s41440-020-00590-1
Number of participants that the trial has enrolled	255
Results	Background treatment with metformin diminished the SGLT2i induced reductions in eGFR after 3 months of SGLT2i therapy in patients with type 2 diabetes and hypertension(-2.29  vs -5.85  mL/min/1.73m2  for metformin users (n=126) and nonusers (n=97), respectively).
Results date posted	2022 Year 06 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 12 Month 04 Day
Baseline Characteristics	N (male female)　223 (149/74) Age (y/o) 58.1 Body weight (kg) 77.9 BMI (kg/m2) 28.4 HbA1c (%) 7.89 LDL-cholesterol (mg/dL) 108.4 eGFR (mL/min/1.73 m2) N (%) >90 44 (19.7%) 90 > >60 120 (53.8%) 60 > >45 38 (17.0%) 45 > >30 13 (5.8%) 30 >  8 (3.6%)
Participant flow	A total of 255 patients were selected and 223 who did not meet the exclusion criteria were validated.
Adverse events	None
Outcome measures	The following items were evaluated at months 0, 3, 6, and 12 Blood pressure Body weight eGFR HbA1c Cr LDL-C Mg
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 01 Month 01 Day
Date of IRB	2019 Year 05 Month 31 Day
Anticipated trial start date	2019 Year 01 Month 02 Day
Last follow-up date	2019 Year 06 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	patient characteristics Age BW BMI HbA1c Systolic BP Diastolic BP LDL-C Mg eGFR Albuminuria medications RAS inhibitor Calcium channel blocker Be-ta blocker DPP4 inhibitor GLP-1 inhibitor

Management information
Registered date	2019 Year 06 Month 12 Day
Last modified on	2022 Year 06 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042107