UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study between effects of insulin degludec and glargine U300 on nighttime blood glucose fluctuation -Investigasion using flash glucose monitoring system-
Title of the study (Brief title)	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	Yukihiro Bando
Organization	Fukuiken Saiseikai Hospital
Division name	Internal medicine
Address	Funabashi Wadanaka 7-1,Fukui,Fukui.Japan
TEL	0776231111
Email	bando.yukihiro5002@fukui.saiseikai.or.jp

Public contact
Name of contact person	Kazuo Notsumata
Organization	Fukuiken Saisekai Hospital
Division name	Internal medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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