UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040044 |
|---|---|
| Receipt number | R000045653 |
| Scientific Title | Effects of switching from Liraglutide to Semaglutide or Dulaglutide in patients with type 2 diabetes:a randomized controlled study |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2023/02/24 11:57:14 |
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Basic information
Public title
Effects of switching from Liraglutide to Semaglutide or Dulaglutide in patients with type 2 diabetes:a randomized controlled study
Acronym
Effects of switching from Liraglutide to Semaglutide or Dulaglutide in patients with type 2 diabetes:a randomized controlled study
Scientific Title
Effects of switching from Liraglutide to Semaglutide or Dulaglutide in patients with type 2 diabetes:a randomized controlled study
Scientific Title:Acronym
Effects of switching from Liraglutide to Semaglutide or Dulaglutide in patients with type 2 diabetes:a randomized controlled study
Region
| Japan |
Condition
Condition
Type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with type 2 diabetes, once-daily liraglutide will be changed to a once-weekly formulation of semaglutide 0.5 mg or duraglutide 0.75 mg and administered for 6 months to compare the efficacy of blood glucose improving effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
difference of HbA1c value from baseline 6 months after the start of study
Key secondary outcomes
body weight, blood pressure, pulse rate, liver function, renal function, uric acid, urinary microalbumin, C-peptide, complications including diabetic retinopathy, adverse events, DTSQc
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
semaglutide
Interventions/Control_2
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 are over 20 years old at registration (regardless of gender)
(2)Patients diagnosed with type 2 diabetes
(3)Patients using liraglutide (0.6mg/0.9mg)
(4)Patients who have not been treated with a new diabetes drug for more than 3 months
(5)Patients who give their consent to participate in this study
Key exclusion criteria
(1) Patients with severe liver damage (up to 3 times normal upper limit of AST and ALT within 28 days before registration)
(2) Patients with severe congestive heart failure and acute heart failure
(3) Patients taking steroids
(4) Patients with a history of diabetic ketoacidosis or diabetic coma during the past 6 months
(5) Cancer patients currently undergoing treatment
(6) Patients with severe infections, before and after surgery, with severe trauma
(7) Patients who are contraindicated or allergic to the test drug
(8) Pregnant, possibly pregnant, or wishing to become pregnant during the treatment period and lactating patients
(9) Patients who participated in clinical trials or clinical trials of drugs or medical devices at the same time as this study or within 30 days before enrollment in this study
(10) Other patients who are judged to be unsuitable as subjects by the judgment of a doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Terauchi |
| Middle name | |
| Last name | Yasuo |
Organization
Yokohama City University Hospital
Division name
Department of Endocrinology & Metabolism
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2800
terauchi@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Iijima |
| Middle name | |
| Last name | Takahiro |
Organization
Yokosuka Kyosai Hospital
Division name
Department of Endocrinology & Metabolism
Zip code
238-8558
Address
1-16 Yonegahamadori, Yokosuka, Kanagawa
TEL
046-822-2710
Homepage URL
takahiro-iijima@umin.ac.jp
Sponsor or person
Institute
Yokosuka Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
045-787-2800
onodera@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
B181004006
Org. issuing International ID_1
Yokohama City University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | 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
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 03 | Day |
Last modified on
| 2023 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045653
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