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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042369
Receipt No. R000048010
Scientific Title Comparison of the effect on glycemic control and quality of life between semaglutide and, liraglutide or dulaglutide in patients with type 2 diabetes -prospective randomized controlled trial- (SWITCH-SEMA 1)
Date of disclosure of the study information 2020/11/06
Last modified on 2021/08/17

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Basic information
Public title Study for the effects of semaglutide on glycemic control and quality of life in patients with type 2 diabetes
Acronym Semaglutide study (SWITCH-SEMA 1)
Scientific Title Comparison of the effect on glycemic control and quality of life between semaglutide and, liraglutide or dulaglutide in patients with type 2 diabetes
-prospective randomized controlled trial- (SWITCH-SEMA 1)
Scientific Title:Acronym Semaglutide study (SWITCH-SEMA 1)
Region
Japan

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

Objectives
Narrative objectives1 To assess the effects of switching from liraglutide or dulaglutide to once-weekly semaglutide on glycemic control and QOL in patients with type 2 diabetes.
(Plan A: Liraglutide to semaglutide; Plan B: Duraglutide to semaglutide)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The change in HbA1c from baseline at 24 weeks
Key secondary outcomes 1) The change in QOL scores
2) Adverse effects
3) The change in weight, abdominal circumference, blood pressure and pulse
4) The change in the other blood and urinary tests
5) The factors associated with improvement of HbA1c and secondary endpoints
6) Comparison of the changes between plan A and B when semaglutide demonstrates the superiority compared to both conventional GLP-1 receptor agonists

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 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Switching from liraglutide (0.9-1.8mg/day) to once-weekly semaglutide (0.25-1.0mg/week)
Interventions/Control_2 Continue liraglutide (0.9-1.8mg/day)
Interventions/Control_3 Switching from dulaglutide (0.75mg/week) to once-weekly semaglutide (0.25-1.0mg/week)
Interventions/Control_4 Continue dulaglutide (0.75mg/week)
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1) HbA1c 6.0-10.0%
2) BMI >= 22 kg/m2
3) patients who were treated with liraglutide or dulaglutide at least for 12 weeks
4) written informed consent
Key exclusion criteria 1) patients with type 2 diabetes who were treated with GLP-1 receptor agonist other than liraglutide or dulaglutide
2) history of anaphylaxis of semaglutide
3) unstable retinopathy
4) severe hepatic dysfunction or renal dysfunction
5) severe ketosis, diabetic coma
6) severe infection, surgery, serious trauma
7) pregnancy
8) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hideaki
Middle name
Last name Miyoshi
Organization Hokkaido University
Division name Division of Diabetes and Obesity, Graduate School of Medicine
Zip code 060-0838
Address N15W7, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL 011-706-8192
Email hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Akinobu
Middle name
Last name Nakamura
Organization Hokkaido University Hospital
Division name Department of Internal Medicine II
Zip code 060-8648
Address N15W7, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL 011-706-5915
Homepage URL
Email akinbo@huhp.hokudai.ac.jp

Sponsor
Institute Hokkaido University 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 Hokkaido University Certified Review Board
Address Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido
Tel 011-706-7934
Email recjimu@huhp.hokudai.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCT1011200008
Org. issuing International ID_1 Japan Registry of Clinical Trials (jRCT)
Study ID_2 018-005
Org. issuing International ID_2 Hokkaido University Certified Review Board
IND to MHLW

Institutions
Institutions 北海道大学病院(北海道)、青木内科クリニック(北海道)、NTT東日本札幌病院(北海道)、栗原内科(北海道)、さっぽろ糖尿病・甲状腺クリニック(北海道)、自由が丘横山内科クリニック(北海道)、萬田記念病院(北海道)、斗南病院(北海道)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 06 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 09 Month 25 Day
Date of IRB
2020 Year 10 Month 08 Day
Anticipated trial start date
2020 Year 11 Month 06 Day
Last follow-up date
2024 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 11 Month 06 Day
Last modified on
2021 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048010

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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