UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050583 |
|---|---|
| Receipt number | R000057617 |
| Scientific Title | Study for the efficacy and safety of oral semaglutide in subjects with type 2 diabetes -retrospective observation trial |
| Date of disclosure of the study information | 2023/03/14 |
| Last modified on | 2024/09/13 10:06:38 |
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Basic information
Public title
Study for the efficacy and safety of oral semaglutide in subjects with type 2 diabetes
Acronym
Study for the usefulness and safety of oral semaglutide
Scientific Title
Study for the efficacy and safety of oral semaglutide in subjects with type 2 diabetes -retrospective observation trial
Scientific Title:Acronym
Study for the usefulness and safety of oral semaglutide
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 investigate the changes in glycemic control and body weight before and after semaglutide treatment in addition to safety analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
1) The changes in HbA1c before and after semaglutide treatment
2) The safety of semaglutide especially regarding gastrointestinal symptoms and hypoglycemia
Key secondary outcomes
1) The change in body weight
2) The changes in plasma glucose, systolic/diastolic blood pressure, pulse rate, lipid metabolism, liver function, kidney function, proteinuria, and microalbuminuria after 6 months semaglutide treatment
3) The changes in drugs for diabetes, dyslipidemia, and hypertension after 6 months semaglutide treatment
4) Adverse effects
5) Patient background
6) The factors associated with improvement of HbA1c and body weight
7) Effects of continuation or discontinuation of anti-hyperglycemic agents other than semaglutide
8) Effects of medications for the comorbidities on body weight after semaglutide treatment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Subjects with type 2 diabetes who were newly treated with oral-semaglutide between 2/5/2021 to 12/31/2022
Key exclusion criteria
1) Subjects for whom administration of oral semaglutide is contraindicated in the package insert (a history of hypersensitivity to the components of this drug, hyperglycemic emergencies such as diabetic ketoacidosis, severe infections)
2) Subjects who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Hokkaido University Hospital
Division name
Department of diabetology and endocrinology
Zip code
060-0811
Address
North 15 West 7, Kita-ku, Sapporo, Hokkaido, 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 diabetology and endocrinology
Zip code
060-0811
Address
North 15 West 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
hnomoto@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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
North 14, West 5, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）、青木内科クリニック（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）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/endocrj/71/6/71_EJ23-0648/_article
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/endocrj/71/6/71_EJ23-0648/_article
Number of participants that the trial has enrolled
543
Results
Of 543 subjects who met the inclusion criteria, data for 434 subjects were analyzed. After a 6 months of observation period, both glycated hemoglobin and body weight significantly improved: 7.65 +- 1.11% to 6.88 +- 0.91% (p < 0.001) and 80.2 +- 19.2 kg to 77.6 +- 19.2 kg (p < 0.001), respectively. In total, 154 subjects had symptomatic gastrointestinal symptoms and 39 (7.2%) were discontinued semaglutide due to the adverse events. None of the participants experienced severe hypoglycemic events.
Results date posted
| 2024 | Year | 09 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eligible criteria were as follows: 1) a diagnosis as T2D; 2) 20 years of age or more; and 3) newly treated with oral semaglutide from February 2021 to December 2022.
Participant flow
This was a multicenter retrospective observational cohort study. Clinical data for 9-12 months of observation were obtained from the participants' medical records.
Adverse events
Of the 543 subjects who met eligibility criteria, 154 (28.4%) had symptomatic gastrointestinal symptoms. Severe hypoglycemia was not identified during the study period.
Outcome measures
There were two primary endpoints in this study: 1) changes in glycated hemoglobin from baseline; and 2) safety of oral semaglutide assessed by any adverse events leading to drug discontinuation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Laboratory and physical examinations will be compared between week 0 and each examination time point (-6 months, -3 months, -1 month, 3 months, and 6 months after semaglutide administration). Regarding safety, all subjects who started semaglutide will be included. Analysis of other tests will be performed on a Per Protocol Set basis.
Management information
Registered date
| 2023 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057617
