UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042016 |
|---|---|
| Receipt number | 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 16:50:14 |
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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
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
dtsuri@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047952
