UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042670
Receipt number R000048610
Scientific Title Effect of semaglutide on glucose variability and oxidative stress in type 2 diabetes patients
Date of disclosure of the study information 2021/03/31
Last modified on 2023/06/11 22:09:14

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Basic information

Public title

Effect of semaglutide on glucose variability and oxidative stress in type 2 diabetes patients

Acronym

Effect of semaglutide on glucose variability and oxidative stress in type 2 diabetes patients

Scientific Title

Effect of semaglutide on glucose variability and oxidative stress in type 2 diabetes patients

Scientific Title:Acronym

Effect of semaglutide on glucose variability and oxidative stress in type 2 diabetes patients

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aimed to investigate the effects of dulaglutide 0.75mg/week and semaglutide 0.5mg/week on oxidative stress and glucose variability before and 24 weeks after the start of the study.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

oxidative stress and glucose variability

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

semaglutide 0.5mg/week

Interventions/Control_2

dulaglutide 0.75mg/week

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

1)a diagnosis of type 2 diabetes mellitus
2)20 years and over
3)HbA1c 6.5% or more
4)treatment with dulaglutide 0.75mg/week for 12weeks or longer

Key exclusion criteria

1)the use of steroids or anti-inflammatory drugs,
2)diabetic ketosis and coma within 3 months before the study,
3)severe infection, severe trauma, pre-and post-operation,
4)an estimated glomerular filtration rate are within 30mL/min/1.73m2,
5)malignancy,
6)pregnancy
7)Patients who are judged as inappropriate for inclusion by phsicians

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Ohara

Organization

Showa University School of Medicine

Division name

Division of Diabetes and Endocrinology, Department of Internal Medicine

Zip code

142-8666

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo

TEL

03-3784-8000

Email

s6018@nms.ac.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Ohara

Organization

Showa University School of Medicine

Division name

Division of Diabetes and Endocrinology, Department of Internal Medicine

Zip code

142-8666

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo

TEL

03-3784-8000

Homepage URL


Email

s6018@nms.ac.jp


Sponsor or person

Institute

Showa University School of Medicine, Division of Diabetes and Endocrinology, Department of Internal Medicine

Institute

Department

Personal name



Funding Source

Organization

Showa University School of Medicine, Division of Diabetes and Endocrinology, Department of Internal Medicine

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

Ethics comittee specializing in human subgects reserch at the Showa University

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo

Tel

03-3784-8129

Email

gakuji@ofc.showa-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

2021 Year 03 Month 31 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

42

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

Completed

Date of protocol fixation

2020 Year 09 Month 16 Day

Date of IRB

2020 Year 11 Month 19 Day

Anticipated trial start date

2021 Year 04 Month 06 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 12 Month 07 Day

Last modified on

2023 Year 06 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048610


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name