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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025939
Receipt No. R000029461
Scientific Title Evaluation of medication adherence of weekly DPP-4 inhibitor, trelagliptin in treating of type 2 diabetes mellitus
Date of disclosure of the study information 2017/02/01
Last modified on 2019/02/24

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Basic information
Public title Evaluation of medication adherence of weekly DPP-4 inhibitor, trelagliptin in treating of type 2 diabetes mellitus
Acronym Medication adherence of trelagliptin
Scientific Title Evaluation of medication adherence of weekly DPP-4 inhibitor, trelagliptin in treating of type 2 diabetes mellitus
Scientific Title:Acronym Medication adherence of trelagliptin
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 examine the effect of the improvement of medication asherence by weekly DPP-4 inhibitor, trelagliptin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Amount of change in medication asherence after administration 24 weeks later
Key secondary outcomes HbA1c
Body weight
Serum lipid
Urinary albumin excretion
Urinary L-FABP excretion, serum cystatinC,eGFR

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Men and women who were diagnosed with type 2 diabetes mellitus
2.Patients have been taking daily DPP-4 inhibitors for more than 12 weeks
Key exclusion criteria 1.type1 diabetes mellitus
2. Past history of diabetic ketoacidosis, diabetic coma, or bofore coma
3.Severe infection, before and not long after surgery, or patient with severe trauma
4 .Severe liver dysfunction
5.Women with during pregnancy , nursing, or pregnant likelihood
6.Inadequte patient judged by doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Koyano
Organization Juntendo University Urayasu Hospital
Division name Endocrinology and Diabetology
Zip code
Address 2-1-1 Tomioka, Urayasu-city, Chiba 279-0021
TEL 047-353-3111
Email koyano@juntendo-urayasu.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Koyano
Organization Juntendo University Urayasu Hospital
Division name Endocrinology and Diabetology
Zip code
Address 2-1-1Tomioka,Urayasu-city, Chiba 279-0021
TEL 047-353-3111
Homepage URL
Email koyano@juntendo-urayasu.jp

Sponsor
Institute Juntendo University Urayasu Hospital
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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 順天堂大学医学部附属浦安病院(千葉県)

Other administrative information
Date of disclosure of the study information
2017 Year 02 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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 02 Month 01 Day
Last modified on
2019 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029461

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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