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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025502
Receipt No. R000029345
Scientific Title the effect of insulin glargine U300 on variability of glucose level before breakfast and change in HbA1c level -pre and post comparison test by switching from U100 to U300-
Date of disclosure of the study information 2017/02/01
Last modified on 2018/09/07

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Basic information
Public title the effect of insulin glargine U300 on variability of glucose level before breakfast and change in HbA1c level
-pre and post comparison test by switching from U100 to U300-
Acronym evaluation for Fasting PG stabilization by switching therapy from glargine to U300
(FASTAGLU300 Study)
Scientific Title the effect of insulin glargine U300 on variability of glucose level before breakfast and change in HbA1c level
-pre and post comparison test by switching from U100 to U300-
Scientific Title:Acronym evaluation for Fasting PG stabilization by switching therapy from glargine to U300
(FASTAGLU300 Study)
Region
Japan

Condition
Condition diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of switching therapyfrom insulin glargine U100 to U300 in the
same unit on stability for glucose level before breakfast and change in HbA1c level after using self-titration algorithm (3-3-1 algorithm)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes 1.Changes in mean value and standard deviation (SD)of fasting blood glucose in early morning
2.Changes in HbA1c and glycated albumin levels after self-titration algorithm (3-3-1 algorithm)
Key secondary outcomes 1.Contributing factors on SD of fasting blood glucose in early morning
2. Change in patient feeling of use
3. Change in body weight,blood pressure and lipid profile
4.symptomatic or severe hypoglycemia
5. another adverse events and side effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 switching from insulin glargine U100 to U300 in the same unit during 30 days
Interventions/Control_2 adjuasting insulin dose by using self-titration algorithm (3-3-1 algorithm) during 90
days
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
75 years-old >=
Gender Male and Female
Key inclusion criteria (1)patient with type 1 or 2 diabetes treated with once daily insulin glargin for moer than 12 weeks
(2) HbA1c(NGSP) 7.0 - 11.0%
(3) Patients who can continue self-monitoring of fasting blood glucose in early morning
(4) Age, 20 - 50 year old
(5) Patients who can agree to take part in this study
Key exclusion criteria -Patients who do not consent to the study.
-Patients who have had severe ketosis or who have been in a diabetic coma or precoma within the past 6 months.
-Patients who have a severe infection, are in pre/post operation, or have a serious wound.
-Patients who are pregnant, lactating or may become pregnant.
-Patients judged by their primary physician that they are not appropriate to participate the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Bando
Organization Fukuiken Saisekai Hospital
Division name Internal medicine
Zip code
Address Funabashi Wadanaka 7-1,Fukui,Fukui.Japan
TEL 0776231111
Email bando.yukihiro5002@fukui.saiseikai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Notsumata
Organization Fukuiken Saisekai Hospital
Division name Internal medicine
Zip code
Address Funabashi Wadanaka 7-1,Fukui,Fukui.Japan
TEL 0776231111
Homepage URL
Email bando.yukihiro5002@fukui.saiseikai.or.jp

Sponsor
Institute Fukuiken Saisekai Hospital
Institute
Department

Funding Source
Organization no source of funding
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 12 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 10 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 10 Month 15 Day
Date trial data considered complete
2017 Year 10 Month 30 Day
Date analysis concluded
2017 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 03 Day
Last modified on
2018 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029345

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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