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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044159
Receipt No. R000050374
Scientific Title efficacy of semaglutide vs dulaglutide in type 2 diabetes mellitus patients on Hemodialysis
Date of disclosure of the study information 2021/05/10
Last modified on 2021/05/06

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Basic information
Public title efficacy of semaglutide vs dulaglutide in type 2 diabetes mellitus patients on Hemodialysis
Acronym efficacy of semaglutide vs dulaglutide in type 2 diabetes mellitus patients on Hemodialysis
Scientific Title efficacy of semaglutide vs dulaglutide in type 2 diabetes mellitus patients on Hemodialysis
Scientific Title:Acronym efficacy of semaglutide vs dulaglutide in type 2 diabetes mellitus patients on Hemodialysis
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 For outpatients with type 2 diabetes who are using dulaglutide but need glycemic control, switch to semaglutide and Use Continuous Glucose Monitoring (CGM) to compare and evaluate differences in glycemic control on dialysis and non-dialysis days.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage of CGM blood glucose 70-180 mg / dl (normal range) time for 3 days each on HD and non-HD days for each treatment
Key secondary outcomes (1) Percentage of CGM blood glucose level <70 mg / dl (hypoglycemic range) and blood glucose level <54 mg / dl (severe hypoglycemic range) for 3 days each on HD and non-HD days in each treatment method Percentage, blood glucose level 180 mg / dl or higher (hypoglycemic range) time percentage, average blood glucose level, SD value, CV value, M value, MAGE,(2) Changes in HbA1c and glycoalbumin levels, (3) BMI at the end of HD on weekends, (4) BW with one non-dialysis day and BW with two non-dialysis days, (5) Weekend Changes in hANP value after dialysis.

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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Age: 20 years old or older and under 80 years old. 2. Gender: No matter. 3. Those who have been diagnosed with type 2 diabetes more than 1 year before the start of the study and have been treated with dulaglutide for more than 3 months before the screening.4. Glycoalbumin (GA) 20% or more. 5. Those who have passed more than 6 months since the introduction of hemodialysis. 6. A person who has received sufficient explanation for participating in this research, and who has obtained the consent of the document by his / her free will after sufficient understanding.
7. Those who can go to the outpatient clinic according to the research implementation schedule
Key exclusion criteria 1. Patients with a history of severe ketosis, diabetic coma or precoma within 6 weeks of the start of the study. 2. Patients who develop severe hypoglycemia (diabetic coma or precoma, convulsions, etc. that require the assistance of a third party) within 6 weeks of the start of the study.
3. Patients with a history of chronic or idiopathic acute pancreatitis. 4. Patients with a history of acute coronary or cerebrovascular events within 90 days, NYHA class IV heart failure. 5. Patients with proliferative retinopathy (However, patients who have undergone photocoagulation and have stable symptoms can be included). 6. Patients with a history of surgery for serious gastrointestinal disorders. 7. Pregnant or potentially pregnant women and lactating patients. 8. Patients with severe infections, before and after surgery, and with serious trauma. 9. Patients receiving systemic corticosteroids. 10. Patients with severe liver dysfunction (high AST or ALT of 100 U / L or more). 11. Patients with a history of allergies to the drugs to be used in the study. 12. Patients with malignant tumor or history of malignant tumor. 13. Other patients judged by the investigator to be inappropriate as subjects.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name yasuro
Middle name
Last name kumeda
Organization minamiosakahospital
Division name Internal medicine
Zip code 5590012
Address 1-18-18 Higashikagaya, Suminoe-ku, Osaka-shi, Osaka
TEL 06-6685-0221
Email y_kumeda@yahoo.co.jp

Public contact
Name of contact person
1st name shoko
Middle name
Last name miyamoto
Organization minamiosakahospital
Division name Internal medicine
Zip code 5590012
Address 1-18-18 Higashikagaya, Suminoe-ku, Osaka-shi, Osaka
TEL 06-6685-0221
Homepage URL
Email sh0k0.w.0128@gmail.com

Sponsor
Institute minamiosakahospital, Internal medicine
Institute
Department

Funding Source
Organization minamiosakahospital
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 minamiosakahospital
Address 1-18-18 Higashikagaya, Suminoe-ku, Osaka-shi, Osaka
Tel 06-6685-0221
Email sh0k0.w.0128@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 南大阪病院(大阪府)

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 10 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
Results
Results date posted
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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 10 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information minamiosakahospital

Management information
Registered date
2021 Year 05 Month 10 Day
Last modified on
2021 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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