UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025122
Receipt number R000028871
Scientific Title An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus
Date of disclosure of the study information 2017/01/01
Last modified on 2021/07/08 16:27:01

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Basic information

Public title

An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus

Acronym

An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus

Scientific Title

An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus

Scientific Title:Acronym

An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus

Region

Japan


Condition

Condition

type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of insulin glargine U300 and insulin degludec in type 2 diabetes mellitus.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Level of glycohemoglobin (HbA1c) at six months after switching basal insulin

Key secondary outcomes

Fasting blood glucose, body weight, frequency and severity of hypoglycemia, circadian variation in blood glucose (M Value), dosage of insulin, results of the questionnaire about quality of life (QOL) and device convenience


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Insulin glargine U300 will be administered daily for six months. Glargine U300 will be started at the same dose as glargine U100 administered before switching. The dosage of glargine U300 will be adjusted according to the levels of fasting blood glucose self-measured by patients.

Interventions/Control_2

Insulin degludec will be administered daily for six months. Glargine U300 will be started at the same dose as glargine U100 administered before switching. The dosage of degludec will be adjusted according to the levels of fasting blood glucose self-measured by patients.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Outpatients with type 2 diabetes who is administered insulin glargine U100 for over three months

Key exclusion criteria

Patients whose medications for diabetes (kinds or dosages of insulin, GLP-1 agonists or oral hypoglycemic agents) have been changed in last two months

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiro Suzuki, Rie Jo

Organization

Kanagawa-ken Keiyu-kai Keiyu hospital

Division name

Department of internal medicine

Zip code


Address

3-7-3, Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan. 220-8521(Zip code)

TEL

045-221-8181

Email

r.oga925@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Rie Jo

Organization

Kanagawa-ken Keiyu-kai Keiyu hospital

Division name

Department of internal medicine

Zip code


Address

3-7-3, Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan. 220-8521(Zip code)

TEL

045-221-8181

Homepage URL


Email

r.oga925@nifty.com


Sponsor or person

Institute

Kanagawa-ken Keiyu-kai Keiyu hospital

Institute

Department

Personal name



Funding Source

Organization

Kanagawa-ken Keiyu-kai Keiyu hospital

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


Address


Tel


Email



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

一般財団法人神奈川県警友会 けいゆう病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 01 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


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 11 Month 22 Day

Date of IRB

2016 Year 10 Month 01 Day

Anticipated trial start date

2016 Year 12 Month 02 Day

Last follow-up date

2017 Year 12 Month 02 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 02 Day

Last modified on

2021 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028871


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name