UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027364
Receipt number R000031344
Scientific Title Investigation about insulin doses and blood glucose control in changes from insulin glargine U-100 to insulin glargine U-300 for patients with diabetes.
Date of disclosure of the study information 2017/05/17
Last modified on 2020/11/27 15:15:20

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Basic information

Public title

Investigation about insulin doses and blood glucose control in changes from insulin glargine U-100 to insulin glargine U-300 for patients with diabetes.

Acronym

Investigation about insulin doses and blood glucose control in changes from insulin glargine U-100 to insulin glargine U-300 for patients with diabetes.

Scientific Title

Investigation about insulin doses and blood glucose control in changes from insulin glargine U-100 to insulin glargine U-300 for patients with diabetes.

Scientific Title:Acronym

Investigation about insulin doses and blood glucose control in changes from insulin glargine U-100 to insulin glargine U-300 for patients with diabetes.

Region

Japan


Condition

Condition

diabetes mellitus

Classification by specialty

Medicine in general Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy and safety between insulin glargine U-300 for diabetes patients receiving insulin glargine U-100, in addition to evaluate usability by using a questionnaire

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

HbA1c

Key secondary outcomes

satisfaction of the change to insulin glargine U-300 by using Questionnaire, insulin dose, bodyweight, BMI, glucose, a ratio of basal insulin (basal-bolou therapy), hypoglycemia (hypoglycemic symptom or glucose level at self monitering glucose)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

To switch from insulin glargine U-100 to insulin glargin U-300.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)The patient who gives a written informed.
2)The patient who is receiving treatment with insulin glargine u-100 by once or twice a day.
3)Male and Female,the age 20 years old or older.

Key exclusion criteria

1)The pregnant woman and/or a woman under breast-feeding.
2)The patient with intolerance of medical reasons by doctor.
3)The patients with hypersensitivity for insulin glargin U-300.
4)The patients with serious complications and considered inappropriate to participate in this study by the doctor in charge.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Toshie
Middle name
Last name Iijima

Organization

Dokkyo Medical University Hospital

Division name

Department of Endocrinology and Metabolism

Zip code

321-0293

Address

880 kita-kobayashi, Mibu, Tochigi, 321-0293, Japan

TEL

0282-86-1111

Email

toshie@dokkyomed.ac.jp


Public contact

Name of contact person

1st name Toshie
Middle name
Last name Iijima

Organization

Dokkyo Medical University Hospital

Division name

Department of Endocrinology and Metabolism

Zip code

321-0293

Address

880 kita-kobayashi, Mibu, Tochigi, 321-0293, Japan

TEL

0282-86-1111

Homepage URL


Email

toshie@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University

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

Dokkyo Medical University

Address

880 kita-kobayashi, Mibu, Tochigi, 321-0293, Japan

Tel

0282-87-2275

Email

r-kenkyu@dokkyomed.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

獨協医科大学病院(栃木県)


Other administrative information

Date of disclosure of the study information

2017 Year 05 Month 17 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

Completed

Date of protocol fixation

2016 Year 09 Month 01 Day

Date of IRB

2016 Year 10 Month 04 Day

Anticipated trial start date

2016 Year 10 Month 04 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 05 Month 16 Day

Last modified on

2020 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031344


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name