UMIN-CTR Clinical Trial

Basic information
Public title	An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus
Acronym	An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus
Scientific Title	An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus
Scientific Title:Acronym	An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus
Region	Japan

Condition
Condition	type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of insulin glargine U300 and insulin degludec in type 2 diabetes mellitus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Level of glycohemoglobin (HbA1c) at six months after switching basal insulin
Key secondary outcomes	Fasting blood glucose, body weight, frequency and severity of hypoglycemia, circadian variation in blood glucose (M Value), dosage of insulin, results of the questionnaire about quality of life (QOL) and device convenience

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Insulin glargine U300 will be administered daily for six months. Glargine U300 will be started at the same dose as glargine U100 administered before switching. The dosage of glargine U300 will be adjusted according to the levels of fasting blood glucose self-measured by patients.
Interventions/Control_2	Insulin degludec will be administered daily for six months. Glargine U300 will be started at the same dose as glargine U100 administered before switching. The dosage of degludec will be adjusted according to the levels of fasting blood glucose self-measured by patients.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Outpatients with type 2 diabetes who is administered insulin glargine U100 for over three months
Key exclusion criteria	Patients whose medications for diabetes (kinds or dosages of insulin, GLP-1 agonists or oral hypoglycemic agents) have been changed in last two months
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takahiro Suzuki, Rie Jo
Organization	Kanagawa-ken Keiyu-kai Keiyu hospital
Division name	Department of internal medicine
Zip code
Address	3-7-3, Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan. 220-8521(Zip code)
TEL	045-221-8181
Email	r.oga925@nifty.com

Public contact
Name of contact person	1st name Middle name Last name Rie Jo
Organization	Kanagawa-ken Keiyu-kai Keiyu hospital
Division name	Department of internal medicine
Zip code
Address	3-7-3, Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan. 220-8521(Zip code)
TEL	045-221-8181
Homepage URL
Email	r.oga925@nifty.com

Sponsor
Institute	Kanagawa-ken Keiyu-kai Keiyu hospital
Institute
Department

Funding Source
Organization	Kanagawa-ken Keiyu-kai Keiyu hospital
Organization
Division
Category of Funding Organization	Self funding
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	一般財団法人神奈川県警友会　けいゆう病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2017 Year 01 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	Terminated
Date of protocol fixation	2016 Year 11 Month 22 Day
Date of IRB	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 02 Day
Last follow-up date	2017 Year 12 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 02 Day
Last modified on	2021 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028871