UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025502 |
|---|---|
| Receipt number | 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 14:10:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
bando.yukihiro5002@fukui.saiseikai.or.jp
Sponsor or person
Institute
Fukuiken Saisekai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
