UMIN-CTR Clinical Trial

Basic information
Public title	Sodium-glucose cotransporter 2 inhibition reduces body weight but not plasma glucose level in patients with type2 diabetes and mild renal failure
Acronym	Sodium-glucose cotransporter 2 inhibition reduces body weight but not plasma glucose level in patients with type2 diabetes and mild renal failure
Scientific Title	Sodium-glucose cotransporter 2 inhibition reduces body weight but not plasma glucose level in patients with type2 diabetes and mild renal failure
Scientific Title:Acronym	Sodium-glucose cotransporter 2 inhibition reduces body weight but not plasma glucose level in patients with type2 diabetes and mild renal failure
Region	Japan

Condition
Condition	type2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, SGLT 2 inhibitor was administered and the effectiveness to reduce body weight was examined, not to lower the blood glucose level of type 2 diabetic patients with mild renal failure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	HbA1c and body weight
Key secondary outcomes	We compared eGFR> 60 with normal kidney function, eGFR <60 as mild renal failure and comparing changes in body weight change with the two groups of HbA1c.

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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Outpatients 2) over 20 years old 3) T2DM 4) eGFR over 15 mL/min/1.73 m2 5) Diet and exercise therapies are well performed 6) Patients who are suspected good-compliant 7) Understanding of the study procedures and agreement to participate in the study
Key exclusion criteria	1) Patients suspected of having secondary diabetes (ex. endocrine disease, drug-induced or liver disease) 2) Females who are pregnant or who intend to become pregnant within the study 3) Severe hepatic disease, malignancy, a history of gastrectomy and/or positive for HIV 4) Contraindication with SGLT2 inhibitors 5) Patient who disqualified from the study by the investigator for any reason other than given above.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shinji Middle name Last name Taneda
Organization	Manda Memorial Hospital
Division name	Diabetes Center
Zip code	060-0062
Address	Minami 2, Nishi 1, Chuo-ku, Sapporo
TEL	011-231-4032
Email	taneda@manda.or.jp

Public contact
Name of contact person	1st name Yasuhiro Middle name Last name Iijima
Organization	Manda Memorial Hospital
Division name	Diabetes Center
Zip code	060-0062
Address	Minami 2, Nishi 1, Chuo-ku, Sapporo
TEL	011-231-4032
Homepage URL
Email	yasuhiro.iijima1203@gmail.com

Sponsor
Institute	Manda Memorial Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Manda Memorial Hospital
Address	Minami 2, Nishi 1, Chuo-ku, Sapporo
Tel	011-231-4032
Email	taneda@manda.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	萬田記念病院（北海道）

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 26 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	80
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	Completed
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 10 Month 28 Day
Anticipated trial start date	2018 Year 10 Month 28 Day
Last follow-up date	2019 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2019 Year 09 Month 26 Day
Last modified on	2019 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043418