UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038103
Receipt number R000043418
Scientific Title Sodium-glucose cotransporter 2 inhibition reduces body weight but not plasma glucose level in patients with type2 diabetes and mild renal failure
Date of disclosure of the study information 2019/09/26
Last modified on 2019/09/26 09:45:56

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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 or person

Institute

Manda Memorial Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043418


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name