UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024552 |
|---|---|
| Receipt number | 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 22:05:55 |
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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
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
hmiyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028119
