UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044264 |
|---|---|
| Receipt number | 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 | 2023/05/27 11:29:49 |
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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
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
tomohiko@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasai Medical School
Institute
Department
Personal name
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
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
120
Results
The primary endpoint was the difference of HbA1c level between 2 groups at 24 weeks.
The HbA1c level at 24 weeks was significantly lower in S than D. Reduction in BMI and VFA levels were also more significant in S, BMI: 29.2 to 28.8 vs. 29.4 to 28.1
Results date posted
| 2023 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Backgrounds of 107 subjects Group D: Group S vs 54:53 were age 62.7 years, disease duration 13.9 years, BMI 29.3 kg/m2, HbA1c 8.0%, DPP4. There was no inter-group difference in the rate of inhibitor use.
Participant flow
Enrolled cases (n=120)
Assignment to dulaglutide (n=59) to Consent withdrawal (n=1) to Administration of dulaglutide (n=58) to Discontinuation of treatment (n=5) to Full set analysis (n=53) to Change of other diabetes drugs (n=1)toPer protocol analysis (n=52)
Assignment to semaglutide (n=61) to Consent withdrawal (n=2) to Semaglutide administration (n=59) to Treatment discontinuation (n=5) to Full set analysis (n=54) to Per protocol analysis (n=54)
Adverse events
Dulaglutide group: Gastrointestinal symptoms 7 (13.2%) Nausea 4 (7.5%) Constipation 1 (1.9%) Diarrhea 1 (1.9%) Abdominal bloating 1 (1.9%) Itching at injection site 1 (1.9%) Herpes labialis 1 ( 1.9%)
Semaglutide group: Gastrointestinal symptoms 25 (46.3%) Nausea 20 (37.0%) Constipation 7 (13.0%) Diarrhea 2 (3.7%) Abdominal bloating 1 (1.9%) Heart failure 1 (1.9%) Taste disturbance 1 (1.9%)
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2023 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050554
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