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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024552
Receipt No. R000028119
Scientific Title Investigation of satisfaction, efficacy and safety after switching from daily GLP-1 receptor agonist to weekly dulaglutide in patients with type 2 diabetes -open label, randomized, parallel group controlled clinical study-
Date of disclosure of the study information 2016/11/01
Last modified on 2018/12/26

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Basic information
Public title Investigation of satisfaction, efficacy and safety after switching from daily GLP-1 receptor agonist to weekly dulaglutide in patients with type 2 diabetes
-open label, randomized, parallel group controlled clinical study-
Acronym Study for satisfaction and efficacy of dulaglutide
Scientific Title Investigation of satisfaction, efficacy and safety after switching from daily GLP-1 receptor agonist to weekly dulaglutide in patients with type 2 diabetes
-open label, randomized, parallel group controlled clinical study-
Scientific Title:Acronym Study for satisfaction and efficacy of dulaglutide
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess patients satisfaction, efficacy and safety of weekly GLP-1 receptor agonist compared with daily GLP-1 receptor agonist
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The score of Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Key secondary outcomes 1)The score of Diabetes Therapy Related Quality of life (DTR-QOL)
2)Plasma glucose and HbA1c
3)Body weight and body mass index (BMI)
4)Blood test
5)The assessment of safety: frequency of hypoglycemia, digestive symptom, and so on

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Keeping daily GLP-1 receptor agonist
Interventions/Control_2 Switching from daily GLP-1 receptor agonist to dulaglutide
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)Patients who were 20-year-old or older at the time of obtaining informed consent
2)Patients whose HbA1c level is more than 6.0% and less than 9.0% at the time of obtaining informed consent
3)Patients who were taking GLP-1 receptor agonist more than three months
4)Patients who are able to understand the study and willing to provide written informed consent
Key exclusion criteria 1)Patients who were taking weekly GLP-1 receptor agonist at the time of obtaining informed consent
2)Patients who have experienced severe diabetic ketosis, diabetic coma, or past history of pre-coma within six months
3)Patients with pregnancy or lactation
4)Patients who are taking systemic corticosteroid
5)Type 1 diabetes
6)Patients with severe infection, pre or post operation and severe trauma
7)Patients with severe liver dysfunction
8)Patients with severe renal dysfunction
9)Patients who are deemed to be unsuitable by the investigator
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Miyoshi
Organization Hokkaido University Graduate School
Division name Division of Rheumatology, Endocrinology and Nephrology
Zip code
Address N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5915
Email hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Miyoshi
Organization Hokkaido University Graduate School
Division name Division of Rheumatology, Endocrinology and Nephrology
Zip code
Address N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5915
Homepage URL
Email hmiyoshi@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School
Institute
Department

Funding Source
Organization Hokkaido University Graduate School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2016 Year 11 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 Completed
Date of protocol fixation
2016 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 06 Day
Last follow-up date
2017 Year 07 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 24 Day
Last modified on
2018 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028119

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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