UMIN-CTR Clinical Trial

Basic information
Public title	Examination of equivalence between biosimilar and original in insulin lispro
Acronym	Examination of equivalence between biosimilar and original in insulin lispro
Scientific Title	Examination of equivalence between biosimilar and original in insulin lispro
Scientific Title:Acronym	Examination of equivalence between biosimilar and original in insulin lispro
Region	Japan

Condition
Condition	Type 1 and type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of the rapid insulin lispro and biosimilar on daily blood glucose profile.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	By wearing CGM, and blood glucose is continuously monitored weekly using each insulin to evaluate daily blood glucose profile (AUC).
Key secondary outcomes	(1) Change in Body weight (2) Number of occurrences of hypoglycemia (3) Variation of daily blood glucose profile (4) Comparison of average blood glucose revel from CGM data

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administer insulin lispro, which has been used so far, for 1 week, then change to biosimilar at the same dose and administer for 1 week.
Interventions/Control_2
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	Patients with type 1 or type 2 diabetes who have been treated with insulin lispro for at least 3 consecutive months before the start of this study
Key exclusion criteria	1. Patients with severe ketosis, diabetic coma or precoma 2. Patients with severe infections, before and after surgery, and with serious external injury 3. Patients with severe renal dysfunction or end-stage renal disease on dialysis 4. Patients that the attending physician deems inappropriate for this study for other reasons
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Tsuriya
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	431-3192
Address	1-20-1 handayama higashi-ku Hamamatsu city
TEL	053-435-2263
Email	dtsuri@hama-med.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Tsuriya
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	431-3192
Address	1-20-1 handayama higashi-ku Hamamatsu city
TEL	053-435-2263
Homepage URL
Email	dtsuri@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Second Division, Department of Internal Medicine,Hamamatsu University School of Medicine
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	Clinical Research Ethics Committee of Hamamatsu University School of Medicine
Address	1-20-1 handayama higashi-ku Hamamatsu city
Tel	053-435-2680
Email	rinri@hama-med.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	浜松医科大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 06 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	Preinitiation
Date of protocol fixation	2020 Year 08 Month 18 Day
Date of IRB	2020 Year 09 Month 01 Day
Anticipated trial start date	2020 Year 10 Month 12 Day
Last follow-up date	2023 Year 07 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	2020 Year 10 Month 05 Day
Last modified on	2020 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047952