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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040044
Receipt No. 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 2021/04/12

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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
Email 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
Email takahiro-iijima@umin.ac.jp

Sponsor
Institute Yokosuka Kyosai Hospital
Institute
Department

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
Email 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 Open public recruiting
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
2023 Year 08 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
2020 Year 04 Month 03 Day
Last modified on
2021 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045653

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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