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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025122
Receipt No. 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 2016/12/02

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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
Institute Kanagawa-ken Keiyu-kai Keiyu hospital
Institute
Department

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
Date of protocol fixation
2016 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 02 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
2016 Year 12 Month 02 Day
Last modified on
2016 Year 12 Month 02 Day


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


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