UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050659 |
|---|---|
| Receipt number | R000057699 |
| Scientific Title | Efficacy of pharmacist intervention for a patient who takes incretin modulator. |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2025/03/19 14:11:54 |
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Basic information
Public title
Efficacy of pharmacist intervention for a patient who takes incretin modulator.
Acronym
Efficacy of pharmacist intervention for a patient who takes incretin modulator.
Scientific Title
Efficacy of pharmacist intervention for a patient who takes incretin modulator.
Scientific Title:Acronym
Efficacy of pharmacist intervention for a patient who takes incretin modulator.
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pharmacist provide a patient who takes incretin modulator with non-pharmacotherapy of guidance and manage side effects, that test the efficacy of pharmacist intervention in the field of diabetes treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body weight
Key secondary outcomes
(1)HbA1c
(2)body weight
(3)adherence
(4)side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
sleep guidance
Interventions/Control_2
exercise guidance
Interventions/Control_3
manage side effects
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)A person who uses DPP-4 inhibitor or GLP-1 receptor agonist for more than 6 months.
(2)Over 18 years of age.
Key exclusion criteria
(1)A person who already running sleep guidance and exercise guidance.
(2)When if give exercise guidance, A person who occurs cardiovascular disease, retinopathy, nephropathy, neuropathy and orthopedic disease.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yumeka |
| Middle name | |
| Last name | WASHIO |
Organization
Chiba Pharmaceutical Association
Division name
Drug Information Center
Zip code
260-0025
Address
9-2 Tonyacho, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-247-4401
drug-info@c-yaku.or.jp
Public contact
Name of contact person
| 1st name | Yumeka |
| Middle name | |
| Last name | WASHIO |
Organization
Chiba Pharmaceutical Association
Division name
Drug Information Center
Zip code
260-0025
Address
9-2 Tonyacho, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-247-4401
Homepage URL
drug-info@c-yaku.or.jp
Sponsor or person
Institute
Chiba Pharmaceutical Association
Institute
Department
Personal name
Funding Source
Organization
Chiba Pharmaceutical Association
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
Ethical Review Board, Chiba Pharmaceutical Association
Address
9-2 Tonyacho, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-247-4401
drug-info@c-yaku.or.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
Terminated
Date of protocol fixation
| 2023 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2023 | Year | 03 | Month | 23 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057699
