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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044264
Receipt No. R000050554
Scientific Title Comparison of clinical efficacy and safety of weekly GLP-1 receptor agonists dulaglutide and semaglutide
Date of disclosure of the study information 2021/06/10
Last modified on 2021/05/19

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Basic information
Public title Comparison of clinical efficacy and safety of weekly GLP-1 receptor agonists dulaglutide and semaglutide
Acronym Comparison of clinical efficacy and safety of dulaglutide and semaglutide
Scientific Title Comparison of clinical efficacy and safety of weekly GLP-1 receptor agonists dulaglutide and semaglutide
Scientific Title:Acronym Comparison of clinical efficacy and safety of dulaglutide and semaglutide
Region
Japan

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

Objectives
Narrative objectives1 In outpatients with type 2 diabetes, cases that the attending physician determined to require treatment with a GLP-1 receptor agonist were randomly assigned to the Weekly preparations duraglutide and semaglutide, and the difference in efficacy and frequency of side effects, clarify patient satisfaction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of HbA1c levels between the two groups 6 months after the start of administration.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 dulalutide for 24 weeks
Interventions/Control_2 semaglutide for 24 weeks
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 Men and women over 20 years old at the time of consent acquisition

Patients with HbA1c of 7.0% or more and less than 10.0% at the time of consent, who the attending physician considers to require new treatment with a GLP-1 receptor agonist

HbA1c levels 12 weeks prior to the start of treatment in this study are available and recorded

Patients who have received sufficient explanation before participating in this study, and who have fully understood and consented to the document by their own free will.

Patients who have not started a new diabetes drug or changed the dose for 12 weeks until consent is obtained
Key exclusion criteria Type 1 diabetes patient

Patients using insulin

Patients treated with GLP-1 receptor agonist within 3 months

Patients with a history of severe ketosis, diabetic coma, or precoma within the last 6 months

Pregnant or potentially pregnant women and lactating patients

Diabetic patients with specific mechanisms and diseases (exocrine pancreatic disease, endocrine disease, drug-induced, hereditary)

Cases during steroid administration

Patients with malignant tumors

Patients with severe infections, before and after surgery, and with serious trauma

Patients with severe liver damage

Other cases judged to be inappropriate
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Tomohiko
Middle name
Last name Kimura
Organization Kawasai Medical School
Division name Diabetes obesity and metabolism
Zip code 700-0192
Address 577, Matsushima, Kurashiki-city, Okayama
TEL 086-462-1111
Email tomohiko@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Tomohiko
Middle name
Last name Kimura
Organization Kawasai Medical School
Division name Diabetes obesity and metabolism
Zip code 700-0192
Address 577, Matsushima, Kurashiki-city, Okayama
TEL 086-462-1111
Homepage URL
Email tomohiko@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasai Medical School
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 Institutional Review Board of Kawasaki Medical School
Address 577, Matsushima, Kurashiki-city, Okayama
Tel 086-462-1111
Email kmsrec@med.kawasaki-m.ac.jp

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
2021 Year 06 Month 10 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 Preinitiation
Date of protocol fixation
2021 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 08 Day
Last follow-up date
2024 Year 05 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
2021 Year 05 Month 19 Day
Last modified on
2021 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050554

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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