UMIN-CTR Clinical Trial

Public title

Study for the effects of semaglutide on glycemic control and quality of life in patients with type 2 diabetes

Acronym

Semaglutide study (SWITCH-SEMA 1)

Scientific Title

Comparison of the effect on glycemic control and quality of life between semaglutide and, liraglutide or dulaglutide in patients with type 2 diabetes
-prospective randomized controlled trial- (SWITCH-SEMA 1)

Scientific Title:Acronym

Semaglutide study (SWITCH-SEMA 1)

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the effects of switching from liraglutide or dulaglutide to once-weekly semaglutide on glycemic control and QOL in patients with type 2 diabetes.
(Plan A: Liraglutide to semaglutide; Plan B: Duraglutide to semaglutide)

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

The change in HbA1c from baseline at 24 weeks

Key secondary outcomes

1) The change in QOL scores
2) Adverse effects
3) The change in weight, abdominal circumference, blood pressure and pulse
4) The change in the other blood and urinary tests
5) The factors associated with improvement of HbA1c and secondary endpoints
6) Comparison of the changes between plan A and B when semaglutide demonstrates the superiority compared to both conventional GLP-1 receptor agonists

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Switching from liraglutide (0.9-1.8mg/day) to once-weekly semaglutide (0.25-1.0mg/week)

Interventions/Control_2

Continue liraglutide (0.9-1.8mg/day)

Interventions/Control_3

Switching from dulaglutide (0.75mg/week) to once-weekly semaglutide (0.25-1.0mg/week)

Interventions/Control_4

Continue dulaglutide (0.75mg/week)

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

1) HbA1c 6.0-10.0%
2) BMI >= 22 kg/m2
3) patients who were treated with liraglutide or dulaglutide at least for 12 weeks
4) written informed consent

Key exclusion criteria

1) patients with type 2 diabetes who were treated with GLP-1 receptor agonist other than liraglutide or dulaglutide
2) history of anaphylaxis of semaglutide
3) unstable retinopathy
4) severe hepatic dysfunction or renal dysfunction
5) severe ketosis, diabetic coma
6) severe infection, surgery, serious trauma
7) pregnancy
8) patients who are inadequate to enter this study due to the other reasons by physician's judgments

Target sample size

100

Name of lead principal investigator

1st name	Hideaki
Middle name
Last name	Miyoshi

Organization

Hokkaido University

Division name

Division of Diabetes and Obesity, Graduate School of Medicine

Zip code

060-0838

Address

N15W7, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan

TEL

011-706-8192

Email

hmiyoshi@med.hokudai.ac.jp

Name of contact person

1st name	Akinobu
Middle name
Last name	Nakamura

Organization

Hokkaido University Hospital

Division name

Diabetes and Endocrinology

Zip code

060-8648

Address

N15W7, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan

TEL

011-706-5915

Homepage URL

Email

akinbo@huhp.hokudai.ac.jp

Institute

Hokkaido University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hokkaido University Certified Review Board

Address

Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido

Tel

011-706-7934

Email

recjimu@huhp.hokudai.ac.jp

Secondary IDs

YES

Study ID_1

jRCT1011200008

Org. issuing International ID_1

Japan Registry of Clinical Trials (jRCT)

Study ID_2

018-005

Org. issuing International ID_2

Hokkaido University Certified Review Board

IND to MHLW

Institutions

北海道大学病院（北海道）、青木内科クリニック（北海道）、NTT東日本札幌病院（北海道）、栗原内科（北海道）、さっぽろ糖尿病・甲状腺クリニック（北海道）、自由が丘横山内科クリニック（北海道）、萬田記念病院（北海道）、斗南病院（北海道）

Date of disclosure of the study information

2020

Year

11

Month

06

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/36722623/

Number of participants that the trial has enrolled

110

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

Recruitment status

Main results already published

Date of protocol fixation

2020

Year

09

Month

25

Day

Date of IRB

2020

Year

10

Month

08

Day

Anticipated trial start date

2020

Year

11

Month

06

Day

Last follow-up date

2024

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

06

Day

Last modified on

2023

Year

05

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048010