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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027364
Receipt No. 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 2017/05/16

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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
Middle name
Last name Toshie Iijima
Organization Dokkyo Medical University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
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
Middle name
Last name Toshie Iijima
Organization Dokkyo Medical University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 880 kita-kobayashi, Mibu, Tochigi, 321-0293, Japan
TEL 0282-86-1111
Homepage URL
Email toshie@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
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
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 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
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
2017 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.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


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