UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050476 |
|---|---|
| Receipt number | R000057492 |
| Scientific Title | A Prospective Observational Study of patients who switched from SGLT2 inhibitor tablets to luseogliflozin OD film formulation in terms of feeling, Efficacy and Safety of taking the medicine. |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/03/02 21:35:41 |
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Basic information
Public title
A Prospective Observational Study of patients who switched from SGLT2 inhibitor tablets to luseogliflozin OD film formulation in terms of feeling, Efficacy and Safety of taking the medicine.
Acronym
A Survey of feeling of taking Lusefi OD film formulation
Scientific Title
A Prospective Observational Study of patients who switched from SGLT2 inhibitor tablets to luseogliflozin OD film formulation in terms of feeling, Efficacy and Safety of taking the medicine.
Scientific Title:Acronym
A Survey of feeling of taking Lusefi OD film formulation
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 evaluate the effect of switching the dosage form of SGLT2 inhibitors from tablets to OD films on the feeling of taking the drug, adherence, weight, liver enzymes and glycemic control status (1.5-AG, glycoalbumin, HbA1c).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) OHA-Q ver.2 after 1 month of switching
2) The change from baseline in HbA1c after 6 months of switching
Key secondary outcomes
1) Change over time from baseline in HbA1c up to 6 months after the switch
2) Change over time in the following items a) to d) up to 6 months after the switch
a) 1.5-AG
b) GA
c) Liver enzymes(AST,ALT,GGT)
d) Weight
3) Adherence(Pill Counting)
4) Stratified analysis of the following a) to c)
a) By each SGLT2 inhibitor
b) By patient background
c) By medication adherence
5) OHA-Q ver.2 after 6 months of switching
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with type 2 diabetes mellitus who have been switched from Lusefi tablets to Lusefi OD film, or from other SGLT-2 inhibitors to Lusefi OD film.
(2) Patients who have consented to the purpose of this survey
Key exclusion criteria
(1) Patients who changed from Lusefi OD film to Lusefi tablets or other SGLT-2 inhibitor tablets during the study period.
(2) Patients who have changed or added other hypoglycemic drugs.
(3) Patients who have their medications packaged in a single package.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Sugawara |
Organization
Mittel Pharmacy Kaisei
Division name
Kaisei
Zip code
963-8041
Address
6-192-1,Kaisei,Koriyama,Fukushima
TEL
024-935-7336
h.sugawara@mittel.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Seino |
Organization
Seino internal Medicine Clinic
Division name
internal Medicine
Zip code
963-8041
Address
6-192-2,Kaisei,Koriyama,Fukushima
TEL
024-983-1024
Homepage URL
info@seino-clinic.jp
Sponsor or person
Institute
Seino internal Medicine Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mittel Pharmacy Kaisei
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seino internal Medicine Clinic Clinical Secretariat
Address
6-192-2,Kaisei,Koriyama,Fukushima
Tel
024-983-1024
kn7jh5@bma.biglobe.ne.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | 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 | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Change over time from baseline in HbA1c up to 6 months after the switch
2) Change over time in the following items a) to d) up to 6 months after the switch
a) 1.5-AG
b) GA
c) Liver enzymes(AST,ALT,GGT)
d) Weight
3) Adherence(Pill Counting)
4) Stratified analysis of the following a) to c)
a) By each SGLT2 inhibitor
b) By patient background
c) By medication adherence
5) OHA-Q ver.2 after 6 months of switching
Management information
Registered date
| 2023 | Year | 03 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057492
| Research Plan | |
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| 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 |
