UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044159
Receipt number 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 2023/03/10 14:58:09

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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 or person

Institute

minamiosakahospital, Internal medicine

Institute

Department

Personal name



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

houjinhonbu@minamiosaka.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

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

7

Results

The number of participants was 7. 3 had difficulty continuing participation. The percentage of time in the normal range of CGM on HD and non-HD days decreased and the glycoalbumin level decreased before and 8 weeks after the start of the study. The percentage of time in the hypoglycemic range increased, the percentage of time in the hyperglycemic range increased, SD values decreased, and BMI at the end of the HD weekend showed little change.

Results date posted

2022 Year 05 Month 11 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 05 Month 11 Day

Baseline Characteristics

Average age 62.6 years, 5 males (1 female), average BMI 24.37, average 6.1 years after introduction of dialysis, 1 person using insulin as a combination drug, 1 person using meglitinide.

Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 03 Month 28 Day

Date of IRB

2021 Year 02 Month 02 Day

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

2023 Year 03 Month 10 Day



Link to view the page

Value
https://center6.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