UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041000 |
|---|---|
| Receipt number | R000046818 |
| Scientific Title | Real-world Evidence for SEmaglutide Treatment in Murakami memorial hospital |
| Date of disclosure of the study information | 2020/07/06 |
| Last modified on | 2022/07/06 09:14:33 |
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Basic information
Public title
Safety and efficacy of once-weekly semaglutide in the initiation and switching from other GLP-1RA in patients with type 2 diabetes
Acronym
Safety and efficacy of once-weekly semaglutide in patients with type 2 diabetes
Scientific Title
Real-world Evidence for SEmaglutide Treatment in Murakami memorial hospital
Scientific Title:Acronym
RESET study
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For patients with type 2 diabetes who are GLP-1RA naive and treated by liraglutide or dulaglutide, to investigate the frequency of gastrointestinal disorders adverse events (GI AEs) for 16 weeks and the change in HbA1c and body weight from baseline to 52 weeks after the initiation of once-weekly semaglutide treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of gastrointestinal disorders
adverse events for 16 weeks
Change in HbA1c, body weight, and GA from baseline to 52 weeks
Key secondary outcomes
Frequency of blood glucose confirmed hypoglycemia(<70 mg/dL)at 16 and 52 weeks
Change in CPR and FPG at 16 and 52 weeks
Effects on body composition at 16 and 52 weeks
Change in HbA1c and body weight at week 16 and 52 by pretreatment and patient background
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Gene |
Interventions/Control_1
Eligible patients are GLP-1RA naive or receiving liraglutide or dulaglutide treatment over 12 weeks before starting the trial except for insulin combination treatment with MDI or BID. Semaglutide 0.25mg will be administered them once weekly subcutaneously for 4 weeks. Semaglutide dose will be escalated to 0.5mg for 4 weeks. Considering blood glucose control and gastrointestinal disorder adverse events, semaglutide dose can be escalated up to 1.0mg once a week.
Previous OHA and basal insulin dose will be continued without dose change except for DPPIV inhibitor. DPPIV inhibitor will be discontinued after the administration of semaglutide once-weekly.
The study intervention period is 52 weeks.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 Diabetes
Age 20 and over
HbA1c over 7%
GLP-1RA naive or receiving liraglutide or
dulaglutide treatment over 12 weeks before starting the trial except for insulin combination treatment with MDI or BID.
Key exclusion criteria
Severe renal impairment (eGFR<30ml/min/1.73m2, end stage at CKD and dialysis)
(dialysis and eGFR less than 30 ml/min)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mizuho |
| Middle name | |
| Last name | Yamabe |
Organization
Murakami Memorial Hospital
Division name
Department of Diabetes
Zip code
722-0014
Address
1-14-26,shinhama,Onomichi-city, Hiroshima,722-0014,Japan
TEL
0848-22-3131
mk-hp2@able.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Mizuho |
| Middle name | |
| Last name | Yamabe |
Organization
Murakami Memorial Hospital
Division name
Department of Diabetes
Zip code
7220014
Address
1-14-26,shinhama,Onomichi-city, Hiroshima,722-0014,Japan
TEL
0848239287
Homepage URL
mizuhoy@urban.ne.jp
Sponsor or person
Institute
Murakami Memorial 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
Murakami Memorial Hospital
Address
1-14-26,shinhama,Onomichi-city, Hiroshima,722-0014,Japan
Tel
0848223131
http://www.murakami-kinen-hp.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
| 2020 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
JDS2022
Publication of results
Unpublished
Result
URL related to results and publications
JDS2022
Number of participants that the trial has enrolled
49
Results
Total HbA1c0week7.24,16week6.80(%)
GA0week15.9,16week14.3(%)
Body weight0week82.46,16week76.77(kg)
Add on OHA group(A)HbA1c 0week7.18,16week6.74(%),Change from another GLP-1RA(G)HbAc0week7.29,16week6.585(%),G Body weight 0week81.69,16week79.14(kg)
HbA1c significant reduction and Body weight loss using SEmaglutide.
Results date posted
| 2022 | Year | 07 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male31,Female18
Age57.7(years)
treatment period9.5(years)
Body weight82.5(kg)
HbA1c7.24(%)
GA15.9(%)
F-CPR1.83 (ng/ml)
Participant flow
Total 49 patients.
Add on OHA group(A)21,
Change from another GLP-1RA28(Dulaglutide18,Laraglutide10)
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 06 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 07 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 07 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 04 | Day |
Last modified on
| 2022 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046818
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/07/05 | 2022JDS抄録375.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
