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 2023/03/23 17:05:25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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

Preinitiation

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

2024 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

2023 Year 03 Month 23 Day

Last modified on

2023 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057699


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name