UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024367
Receipt number R000028048
Scientific Title Evaluation of efficacy in diabetes control of basal insulin plus SGLT-2 inhibitor/GLP-1 receptor agonist/ rapid insulin in patients with type 2 diabetes
Date of disclosure of the study information 2016/10/12
Last modified on 2021/04/17 12:11:52

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Basic information

Public title

Evaluation of efficacy in diabetes control of basal insulin plus SGLT-2 inhibitor/GLP-1 receptor agonist/ rapid insulin in patients with type 2 diabetes

Acronym

Evaluation of efficacy in diabetes control of basal insulin plus SGLT-2 inhibitor/GLP-1 receptor agonist/ rapid insulin

Scientific Title

Evaluation of efficacy in diabetes control of basal insulin plus SGLT-2 inhibitor/GLP-1 receptor agonist/ rapid insulin in patients with type 2 diabetes

Scientific Title:Acronym

Evaluation of efficacy in diabetes control of basal insulin plus SGLT-2 inhibitor/GLP-1 receptor agonist/ rapid insulin

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of basal insulin plus SGLT-2 inhibitor/GLP-1 receptor agonist/ rapid insulin

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in HbA1c after 52 weeks
Change in weight after 52 weeks

Key secondary outcomes

Level of self-monitoring of blood glucose
Frequency of hypoglycemia
Change in amount of insulin


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Basal insulin plus SGLT-2 inhibitor(52 weeks)

Interventions/Control_2

Basal insulin plus GLP-1 receptor agonist (52 weeks)

Interventions/Control_3

Basal insulin plus rapid insulin (52 weeks)

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1. Participants with type 2 diabetes
2. Participants who can perform self-monitoring blood glucose
3. BMI<=45 kg/m2
4. HbA1c between 7.0 to 10.5 %

Key exclusion criteria

1.Participants with severe liver dysfunction
2.Participants with severe renal dysfunction
3.Participants with severe diabetic complications
4.Participants who are pregnant, hope to be pregnant, or are in lactation period
5.Participants whose fasting serum C-peptide immunoreactivity below 0.5ng/ml
6.Participants whose postprandial serum C-peptide immunoreactivity below 0.5ng/ml

Target sample size

75


Research contact person

Name of lead principal investigator

1st name Tetsuya
Middle name
Last name Babazono

Organization

Tokyo Women's Medical University Hospital

Division name

Diabetes center

Zip code

1628666

Address

8-1, Kawadacho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Email

babazono.dmc@twmu.ac.jp


Public contact

Name of contact person

1st name Junko
Middle name
Last name Oya

Organization

Tokyo Women's Medical University Hospital

Division name

Diabetes center

Zip code

1628666

Address

8-1, Kawadacho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Homepage URL


Email

johya.dmc@twmu.ac.jp


Sponsor or person

Institute

Tokyo Women's Medical University 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

NS building Clinic
Tomonaga Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Women's Medical University Hospital

Address

8-1, Kawadacho, Shinjuku-ku, Tokyo

Tel

03-3353-8111

Email

krinri.bm@twmu.ac.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

東京女子医科大学病院(東京都)、NSビルクリニック(東京都)、ともながクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 12 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

15

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

Terminated

Date of protocol fixation

2016 Year 09 Month 28 Day

Date of IRB

2016 Year 09 Month 28 Day

Anticipated trial start date

2016 Year 10 Month 12 Day

Last follow-up date

2018 Year 12 Month 01 Day

Date of closure to data entry

2019 Year 11 Month 01 Day

Date trial data considered complete

2021 Year 04 Month 17 Day

Date analysis concluded

2021 Year 04 Month 17 Day


Other

Other related information



Management information

Registered date

2016 Year 10 Month 11 Day

Last modified on

2021 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028048


Research Plan
Registered date File name
2021/04/17 計画書160822.doc

Research case data specifications
Registered date File name
2021/04/17 計画書160822.doc

Research case data
Registered date File name
2021/04/17 計画書160822.doc