UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026829
Receipt No. 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

* 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 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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030797

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.