UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042016
Receipt No. R000047952
Scientific Title Examination of equivalence between biosimilar and original in insulin lispro
Date of disclosure of the study information 2020/10/06
Last modified on 2020/10/05

* 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 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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.