UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051846 |
|---|---|
| Receipt number | R000059145 |
| Scientific Title | Investigation of factors that predict efficacy when switching from DPP-4 inhibitors to oral semaglutide |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2023/08/07 12:41:21 |
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Basic information
Public title
Investigation of factors that predict efficacy when switching from DPP-4 inhibitors to oral semaglutide
Acronym
Investigation of factors that predict efficacy when switching from DPP-4 inhibitors to oral semaglutide
Scientific Title
Investigation of factors that predict efficacy when switching from DPP-4 inhibitors to oral semaglutide
Scientific Title:Acronym
Investigation of factors that predict efficacy when switching from DPP-4 inhibitors to oral semaglutide
Region
| Japan |
Condition
Condition
Type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively examine and elucidate whether or not there are clinical characteristics that would indicate the efficacy of oral semaglutide in clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We compared the patient characteristics and blood test findings between the achievement group and the non-achievement group in patients who needed to increase the oral semaglutide dose to 14 mg with the goal of HbA1c of less than 7.0%.
Key secondary outcomes
Investigation of the patient background of the achievement group and the non-achievement group and the amount of change in each blood test in patients whose HbA1c was less than 7.0% and required an increase in oral semaglutide dose to 14 mg
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After switching from a DPP-4 inhibitor to oral Libersus 3 mg, oral administration was continued for more than 3 months, and oral medication adherence was good. After explaining the outline of the study and giving informed consent, HbA1c was measured every 3 months, and the oral semaglutide dose was increased to 7 mg and 14 mg every 3 months, with the goal of less than 7.0%. A group that required an increase to oral semaglutide 14 mg and achieved HbA1c <7.0%.
Interventions/Control_2
After switching from a DPP-4 inhibitor to oral Libersus 3 mg, oral administration was continued for more than 3 months, and oral medication adherence was good. After explaining the outline of the study and giving informed consent, HbA1c was measured every 3 months, and the oral semaglutide dose was increased to 7 mg and 14 mg every 3 months, with the goal of less than 7.0%. Requires dose escalation to oral semaglutide 14 mg and fails to achieve HbA1c <7.0%
group.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age> 18years. 2)HbA1c >7.0%, <10.5%. 3)Patients who are receiving DPP-4 inhibitors and have been switched to oral semaglutide 3 mg because the attending physician considers that treatment with a GLP-1 receptor agonist is necessary. 4) HbA1c levels 8-12 weeks prior to the start of treatment in this study must be measured and recorded. 5)Patients who fully understood and provided written consent based on their own free will after receiving a sufficient explanation for participation in this study. 6)Patients who have not started a new antidiabetic drug other than oral semaglutide or changed the dose for 12 weeks before consent.
Key exclusion criteria
1) type 1 diabetes mellitus, 2) insulin-treated patients, 3) treated with a GLP-1 receptor agonist within 3 months prior to the introduction of oral semaglutide 3 mg, 4) severe ketosis within the past 6 months , persons with a history of diabetic coma, 5) women who are pregnant or may become pregnant, and those who are breast-feeding,6) persons suspected of having diabetes due to other specific mechanisms or diseases, 7) being on steroids , 8) malignant tumor, 9) severe infection, serious trauma, 10) ineligible to participate in the study as judged by the attending physician.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Hirotsu |
Organization
Fuji City General Hospital
Division name
Diabetes Endocrinology Hematology
Zip code
417-0048
Address
Shizuoka prefecture Fuji city Takashima town 50 address
TEL
0545-52-1131
hits.hits.hits.hits.0521@gmail.com
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Hirotsu |
Organization
Fuji City General Hospital
Division name
Diabetes Endocrinology Hematology
Zip code
417-0048
Address
Shizuoka prefecture Fuji city Takashima town 50 address
TEL
0545-52-1131
Homepage URL
hits.hits.hits.hits.0521@gmail.com
Sponsor or person
Institute
Fuji City General 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
Fuji City General Hospital
Address
Shizuoka prefecture Fuji city Takashima town 50 address
Tel
0545-52-1131
hits.hits.hits.hits.0521@gmail.com
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
| 2023 | Year | 08 | Month | 07 | 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
30
Results
Comparing the HbA1c less than 7.0% achievement group and the non-achievement group, the non-achievement group had a significantly higher percentage of smokers and alcohol drinkers, and the percentage of those who took 31 minutes or more until breakfast was significantly higher in the achievement group.
Results date posted
| 2023 | Year | 08 | Month | 07 | Day |
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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059145
