UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053023 |
|---|---|
| Receipt number | R000059604 |
| Scientific Title | Investigation from real-world data of high dose oral semaglutide, Retrospective study |
| Date of disclosure of the study information | 2024/12/06 |
| Last modified on | 2024/08/20 15:44:36 |
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Basic information
Public title
Investigation from real-world data of high dose oral semaglutide, Retrospective study
Acronym
Investigation from real-world data of high dose oral semaglutide, Retrospective study
Scientific Title
Investigation from real-world data of high dose oral semaglutide, Retrospective study
Scientific Title:Acronym
Investigation from real-world data of high dose oral semaglutide, Retrospective study
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of Rybelsus, an oral GLP-1 receptor agonist, using real world data
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Value or amount/percentage change of the following items;
- Major blood tests
- Other general blood tests
- vital signs
- body weight, BMI
Percentage of patients achieving <7% HbA1c
Time taken from the start of 3 mg to 14mg of Rybelsus
Questionnaire results on reasons for increasing dose to 14 mg of Rybelsus
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are included in this study;
1. Patients with diabetes who used Rybelsus at least once till 2023/4/20
2. Patients aged 18 years or older at the initiation of this study (at approval by institutional review board)
Key exclusion criteria
Patients who fall into any of the following criteria are excluded from participating in the study;
1. Patients with type 1 diabetes mellitus
2. Patients with excessive drinking of alcohol (net alcohol intake is more than 60g/day for male or 30g/day for female)
3. Patients with dementia
4. Patients who were pregnant during data collection period
5. Patients who were hospitalized for blood glucose management for a week or longer within 12 weeks before and after the index date
6. Patients with poor medication adherence (judged by attending physician)
7. Patients who were started on Reversus at another hospital
8. Patients with other conditions that the attending physician think inappropriate to participate in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Genki |
| Middle name | |
| Last name | Sato |
Organization
Toho University Omori Medical Center
Division name
Diabetes, Metabolism and Endocrinology Center
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
genki.sato@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Genki |
| Middle name | |
| Last name | Sato |
Organization
Toho University Omori Medical Center
Division name
Diabetes, Metabolism and Endocrinology Center
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
genki.sato@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Omori Medical Center
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 Toho University Medical Center Omori Hospital
Address
6-11-1 Omori-nishi, Ota-ku Tokyo
Tel
03-3762-4151
omori.rinri@ext.toho-u.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
| 2024 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s13300-024-01631-5
Number of participants that the trial has enrolled
66
Results
The HbA1c level at 24 weeks following the initiation of 14 mg oral semaglutide was significantly lower than that at baseline. Body weight also decreased significantly over the 24-week period.
Results date posted
| 2024 | Year | 08 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 08 | Month | 07 | Day |
Baseline Characteristics
Most patients were middle-aged (with an average age of approximately 56 years) and overweight or with obesity (with an average BMI of approximately 32 kg/m2). The mean duration of diabetes at baseline was approximately 11 years. At baseline, the mean HbA1c level was 7.4%, and patients were typically managed with two glucose-lowering agents in addition to oral semaglutide. Commonly prescribed glucose-lowering agents included biguanides (64%), sodium-glucose cotransporter 2 (SGLT2) inhibitors (62%), and insulin (24%). The mean duration from the initiation of 3 mg oral semaglutide to the commencement of 14 mg dosing was 136 days. Although the mean estimated glomerular filtration rate (eGFR) remained above 60 mL/min/1.73 m2 (with an average eGFR of approximately 73 mL/min/1.73 m2), alanine transaminase (ALT) levels were mildly elevated, surpassing 30 IU/L (with an average ALT of approximately 33 IU/L).
Participant flow
The 77 initially screened subjects, 11 were deemed ineligible (Fig. 2). Consequently, data analysis was performed for the remaining 66 patients who met the inclusion criteria.
Adverse events
Gastrointestinal disorders emerged as the most prevalent adverse event (10.6%), particularly nausea (7.6%), although predominantly of mild or moderate severity, with no instances of serious adverse events necessitating drug discontinuation.
Outcome measures
The primary endpoint of this study was the change in HbA1c levels 24 weeks after the first prescription of 14 mg oral semaglutide (index date). Secondary endpoints included alterations
over the 24-week period in physical assessments, such as body weight, body mass index (BMI), and blood pressure, as well as metabolic parameters, including liver enzymes, renal function, urine albumin excretion ratio (UACR), lipid profile, and uric acid levels. Additionally, secondary endpoints included HbA1c (other than the primary endpoint), the proportion of patients achieving HbA1c < 7.0%, changes in the number of glucose-lowering medications and total daily dose of insulin, and the occurrence of any adverse events. The percentage of patients who experienced a weight change of - 3% or less and - 5% or less from the index date was also calculated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059604
