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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048528
Receipt No. 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

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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
Email 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
Email y.hajika@minamiosaka.com

Sponsor
Institute Minami Osaka Hospital
Internal Medicine
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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