UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026829 |
|---|---|
| Receipt number | R000030797 |
| Scientific Title | Comparative study between effects of insulin degludec and glargine U300 on nighttime blood glucose fluctuation -Investigasion using flash glucose monitoring system- |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2018/09/07 14:15:25 |
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Basic information
Public title
Comparative study between effects of insulin degludec and glargine U300 on nighttime
blood glucose fluctuation
-Investigasion using flash glucose monitoring system-
Acronym
Effects of insulin degludec and glargine U300 on nighttime blood glucose fluctuation
Scientific Title
Comparative study between effects of insulin degludec and glargine U300 on nighttime
blood glucose fluctuation
-Investigasion using flash glucose monitoring system-
Scientific Title:Acronym
Effects of insulin degludec and glargine U300 on nighttime blood glucose fluctuation
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will compare the effect of insulin degludec and insulin glargine U300 on nocturnal blood glucose fluctuation using FGM (Flash Glucose Monitoring; Freestyle Libre Pro).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
For the first 5 days and last 5 days in the midnight to 6AM time zone
1 mean blood sugar level
2 Standard Deviation
3 Mean amplitude of glucose excursion
Key secondary outcomes
For the first 5 days and last 5 days in the midnight to 6 AM time zone
1 Percentage of time zone with blood glucose level less than 70 mg per dl and its AUC
2 Percentage of time zone with blood sugar level less than 50 mg per dl and its AUC
3 Percentage of time zone with blood glucose level 140 mg per dl and its AUC
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1 Install Freestyle Libre Pro (Abbott) for 2 weeks (one sensor).
2 From day 6, switch the basal insulin from insulin degludec to insulin glargine U300, while keeping the same number of units and injection time.
Interventions/Control_2
1 Install Freestyle Libre Pro (Abbott) for 2 weeks (one sensor).
2 From day 6, switch the basal insulin from insulin glargine U300 to insulin degludec, while keeping the same number of units and injection time.
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 Outpatient visit or hospitalized patients
with diabetes
2 Continue to use insulin deglug or insulin glargine U 300 for three months or more, during which the contents of other diabetes remedies are unchanged
3 HbA1c (NGSP value) is 6% or more but less than 9%
Key exclusion criteria
1 Patients with a clear history of ischemic heart disease (angina, myocardial infarction), ischemic cerebrovascular disease
2 Patients with HbA1c fluctuating by 2% or more within 3 months
3 Severe ketosis, diabetic coma or prematurity
4 Patients with severe infection, preoperative, severe trauma
5 Cases judged by other physicians to be ineligible
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Bando |
Organization
Fukuiken Saiseikai 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 | 06 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 22 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 10 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 02 | 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=R000030797
