UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045270 |
|---|---|
| Receipt number | R000051203 |
| Scientific Title | Comparison of the effect on glycemic control between oral semaglutide and DPP-4 inhibitors in patients with type 2 diabetes -prospective randomized controlled trial- |
| Date of disclosure of the study information | 2021/08/26 |
| Last modified on | 2024/08/29 10:44:14 |
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Basic information
Public title
Study for the effects of oral semaglutide on glycemic control in patients with type 2 diabetes
Acronym
Oral semaglutide study
Scientific Title
Comparison of the effect on glycemic control between oral semaglutide and DPP-4 inhibitors in patients with type 2 diabetes -prospective randomized controlled trial-
Scientific Title:Acronym
Oral semaglutide study
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 DPP-4 inhibitors to oral semaglutide on glycemic control in patients with type 2 diabetes
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 the other blood and urinary tests
2) The change in weight, abdominal circumference, blood pressure and pulse
3) Adverse effects
4) The factors associated with improvement of HbA1c and secondary endpoints
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 considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switch from DPP-4 inhibitors to oral semaglutide
Interventions/Control_2
Continue DPP-4 inhibitors
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) HbA1c 7.0-10.0%
2) BMI >= 18.5 kg/m2
3) patients who were treated with DPP-4 inhibitors at least for 12 weeks before enrollment without discontinuation for more than 1 week
4) written informed consent
Key exclusion criteria
1) patients with type 2 diabetes who were treated with any GLP-1 receptor agonist
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
172
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Hokkaido University Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
060-0838
Address
N15W7, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL
011-706-5915
hnomoto@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Hokkaido University Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
060-0838
Address
N15W7, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL
011-706-5915
Homepage URL
hmiyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
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
Hokkaido University Certified Review Board
Address
N14W5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
Tel
011-706-7934
recjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT1011210032
Org. issuing International ID_1
Japan Registry of Clinical Trials (jRCT)
Study ID_2
020-013
Org. issuing International ID_2
Hokkaido University Certified Review Board
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
174
Results
In total, 174 eligible participants were enrolled; 17 dropped out of the study. Improvement in HbA1c at week 24 was significantly greater when switching to semaglutide compared with DPP-4i continuation . Body weight, lipid profiles and liver enzymes were significantly improved in the semaglutide group than in the DPP-4i continuation group.
Results date posted
| 2024 | Year | 08 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 11 | Day |
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 | 06 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 26 | 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
| 2021 | Year | 08 | Month | 26 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051203
