UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048528 |
|---|---|
| Receipt number | R000055283 |
| Scientific Title | Efficacy and quality of life changes in switching traditional rapid acting insulin to ultra rapid Lispro in patients with type 2 diabetes |
| Date of disclosure of the study information | 2022/08/04 |
| Last modified on | 2022/07/31 17:58:39 |
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Basic information
Public title
Efficacy and quality of life changes in switching traditional rapid acting insulin to ultra rapid Lispro in patients with type 2 diabetes
Acronym
Efficacy and quality of life changes in switching traditional rapid acting insulin to ultra rapid Lispro in patients with type 2 diabetes
Scientific Title
Efficacy and quality of life changes in switching traditional rapid acting insulin to ultra rapid Lispro in patients with type 2 diabetes
Scientific Title:Acronym
Efficacy and quality of life changes in switching traditional rapid acting insulin to ultra rapid Lispro in patients with type 2 diabetes
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 investigate changes in Time in range and quality of life by switching traditional rapid acting insulin to ultra rapid Lispro in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Time in range from Freestyle Libre Pro data and ITR-QOL score by switching traditional rapid acting insulin to ultra rapid Lispro.
Key secondary outcomes
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
Have patients fill out the insulin selection sheet. Patients who are judged to be more suitable for ultra rapid Lispro and who wish to change to it are required to answer the questionnaire (Insulin Therapy Related Quality-of-life Measure:ITR-QOL).Attach continuous blood glucose monitoring (Freestyle Libre Pro) for 14 days to patients who started using ultra rapid Lispro.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Type 2 diabetes patients who have been treated with traditional rapid acting fast-acting insulin for more than 6 months before the study
2) Patients who are judged to be more suitable for ultra rapid Lispro from the insulin selection sheet
Key exclusion criteria
1) Patients allergic to insulin lispro
2) Patients who cannot administer ultra rapid Lispro within 2 minutes before meals and within 20 minutes from the start of meals when necessary.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yuriko |
| Middle name | |
| Last name | Hajika |
Organization
Minami Osaka Hospital
Division name
Internal Medicine
Zip code
559-0012
Address
1-18-18, Higashikagaya, Suminoe-ku, Osaka, Japan
TEL
06-6685-0221
y.hajika@minamiosaka.com
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Hajika |
Organization
Minami Osaka Hospital
Division name
Internal Medicine
Zip code
559-0012
Address
1-18-18, Higashikagaya, Suminoe-ku, Osaka, Japan
TEL
06-6685-0221
Homepage URL
y.hajika@minamiosaka.com
Sponsor or person
Institute
Minami Osaka Hospital
Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Minami Osaka Hospital
Address
1-18-18, Higashikagaya, Suminoe-ku, Osaka, Japan
Tel
06-6685-0221
y.hajika@minamiosaka.com
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 04 | 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
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2022 | Year | 07 | Month | 31 | Day |
Last modified on
| 2022 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055283
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
