UMIN-CTR Clinical Trial

Basic information
Public title	Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Acronym	Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Scientific Title	Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Scientific Title:Acronym	Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Region	Japan

Condition
Condition	Type 1 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the difference that two different ultra-long acting insulin affect the fasting blood glucose fluctuation in type 1 diabetic patients who are depleted of endogenous insulin secretion.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Standard deviation of fasting blood glucose by SMBG
Key secondary outcomes	Nocturnal blood glucose fluctuation index by flash glucose monitoring

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
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	Intervention at glargine-U 300 cross over
Interventions/Control_2	Intervention at degludec cross over
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	99 years-old >
Gender	Male and Female
Key inclusion criteria	1) Type 1 diabetes patients who were confirmed to have CPR of less than 0.2 ng / mL at least twice by a conventional measurement method 2) Long-acting or intermediate insulin injection once a day and MDI of super fast-acting or fast-acting insulin have been treated for more than 1 year 3) SMBG can be implemented 4) FGM can be implemented
Key exclusion criteria	1)HbA1c > 9.0% 2)other medication to affect glucose concentarion 3)severe hypertension(Systolic blood pressure of 180 mmHg or more, diastolic blood pressure of 100 mmHg or more) 4)severe liver dysfunction (Increase of AST, ALT more than 2.5 times normal upper limit) 5)severe renal dysfunction (Cr > 2) 6)severe heart failure (NYHA>2) 7)Recent serious hypoglycemia, recent hospitalization due to ketoacidosis 8)retinopathy with high bleeding risk 9)pregnant or breast-feeding women 10)Cancer patient 11)psychological disorder 12) others inappropriate for this study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Sakaguchi Middle name Last name Kazuhiko
Organization	Kobe University Graduate School of Medicine
Division name	Division of Diabetes and Endocrinology Department of Internal Medicine
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL	81-76-382-5861
Email	kzhkskgc@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Sakaguchi Middle name Last name Kazuhiko
Organization	Kobe University Graduate School of Medicine
Division name	Division of Diabetes and Endocrinology Department of Internal Medicine
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL	81-76-382-5861
Homepage URL
Email	kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute	Division of Diabetes and Endocrinology Department of Internal Medicine,Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	no
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	IRB of Kobe University Hospital
Address	7-5-1, Kusunoiki-Cho, Chuoku, Kobe
Tel	078-382-6669
Email	chiken@med.kobe-u.ac.jp

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	神戸大学医学部附属病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 19 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6250619/
Publication of results	Published

Result
URL related to results and publications	http://dx.doi.org/10.1111/dom.14161
Number of participants that the trial has enrolled	46
Results	Comparing the SD of FBG level, IDeg was noninferior to IGla-300 in SD of FBG.
Results date posted	2021 Year 10 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 08 Month 03 Day
Baseline Characteristics	The participants were individuals with type 1 diabetes whose serum C-peptide immunoreactivity was less than 0.2 ng/mL. 14 male and 32 female participated this study. The age was 53.3 +/- 14.7 years old. The average HbA1c value was 7.6 +/- 0.7 %.
Participant flow	The registration pace was slower than expected. The number of patients registered at each facility was 22 from Kobe University Hospital, accounting for about 50%, while all other facilities had less than 5 patients. There were no patient registrations at three centers. CGM data was insufficient for 14 patients.
Adverse events	During the study period, severe adverse event was not reported.
Outcome measures	The primary aim of the study was evaluation of the noninferiority of IDeg relative to IGlarU300 in terms of day-to-day variability of FBG levels as evaluated by the standard deviation (SD) determined from SMBG data.
Plan to share IPD	No
IPD sharing Plan description	Not applicable

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 01 Day
Date of IRB	2017 Year 11 Month 29 Day
Anticipated trial start date	2018 Year 06 Month 08 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 19 Day
Last modified on	2021 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031895