UMIN-CTR Clinical Trial

Public title

The therapeutic effect of oral Semaglutide in older patients with type 2 diabetes mellitus

Acronym

Effect of oral Semaglutide in older patients

Scientific Title

The therapeutic effect of Oral Semaglutide in older patients with type 2 diabetes mellitus; retrospective study.

Scientific Title:Acronym

Effect of oral Semaglutide in older patients

Region

Japan

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate therapeutic effects of oral semaglutide on glycemic control in older patients with type 2 diabetes mellitus.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The change from baseline in HbA1c after 6 months of treatment

Key secondary outcomes

1) The change of various parameters in blood and urine tests (liver, kidney, lipid, etc.)
2) The changes of weight, abdominal circumference, blood pressure, and pulse rate.
3) Adverse events during observation period
4) Factors contributed to changes in HbA1c and secondary endpoints
5) The change of each factor when the degree of dementia is stratified by the simple cognitive function tests
6) Association between scores of simple cognitive function tests and the change of HbA1c

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who are 65-year-old or older
2) Patients with HbA1c of 7.0% or higher
3) Patients who do not refuse to participate in this study

Key exclusion criteria

1) Patients with a history of hypersensitivity to the components of semaglutide
2) Patients with severe ketosis, diabetic coma or pre-coma
3) Other patients deemed to be unsuitable by the investigator

Target sample size

50

Name of lead principal investigator

1st name	Yuki
Middle name
Last name	Oe

Organization

Hokkaido University Graduate School

Division name

Department of Rheumatology, Endocrinology and Nephrology

Zip code

060-8638

Address

N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Email

o-e.yuki@med.hokudai.ac.jp

Name of contact person

1st name	Yuki
Middle name
Last name	Oe

Organization

Hokkaido University Graduate School

Division name

Department of Rheumatology, Endocrinology and Nephrology

Zip code

060-8638

Address

N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Homepage URL

Email

o-e.yuki@med.hokudai.ac.jp

Institute

Hokkaido University Graduate School

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Otaru general hospital

Name of secondary funder(s)

Organization

Otaru general hospital

Address

1-1-1, Wakamatsu, Otaru, Hokkaido, Japan

Tel

0134-25-1211

Email

tarubyo-jimu@city.otaru.lg.jp

Secondary IDs

YES

Study ID_1

04-001

Org. issuing International ID_1

Otaru general hospital

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

小樽市立病院（北海道）

Date of disclosure of the study information

2022

Year

08

Month

29

Day

URL releasing protocol

https://www.otaru-general-hospital.jp/about/hospital-efforts/rinsyokenkyu/

Publication of results

Published

URL related to results and publications

https://link.springer.com/article/10.1186/s12902-024-01658-6

Number of participants that the trial has enrolled

30

Results

24 subjects were enrolled. Their HbA1c and body weight significantly decreased. Although cognitive function was lower in the late older group, changes in HbA1c showed no difference between the two subgroups (P = 0.66) and it correlated with the insulin secretory capacity rather than cognitive function. Glycemic targets were more likely to be achieved (P < 0.01), but HbA1c excessively decreased in late older subjects who were also using insulin or an insulin secretagogue.

Results date posted

2026

Year

03

Month

02

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

he prevalence of obesity was 33.3% (Early; n = 5, Late; n = 3), but their insulin secretory capacity was preserved. In evaluation of cognitive function, the DASC-8 and HDS-R scores were consistent with cognitive impairment in only 4 (Early; n = 1, Late; n = 3) and 2 (Early; n = 0, Late; n = 2) subjects, respectively, and the others were not found to have impaired cognitive function. The final doses of semaglutide were as follows: 3 mg, n = 5 (Early; n = 4, Late; n = 1); 7 mg, n = 15 (Early; n = 8, Late; n = 7); and 14 mg, n = 4 (Early; n = 1, Late; n = 3).

Participant flow

During the observation period, 44 subjects with T2D were administered oral semaglutide, but at the time of analysis, 10 were excluded because they were < 65 years (n = 8) or had previously subcutaneously administered a GLP-1RA (n = 2). Thus, 34 of the subjects were eligible for inclusion; however, a further 4 were excluded for the following reasons, unrelated to the drug: presence of a malignant tumor (n = 2), self-interruption (n = 1), and deterioration of a comorbidity (n = 1). Details of the adverse events and the reasons for the discontinuation of semaglutide were analyzed in the remaining 30 subjects as a safety analysis. Six of the subjects discontinued the medication, and therefore the remaining 24 subjects were studied with respect to efficacy.

Adverse events

Severe adverse events, defined using the CTCAE, did not occur. Discontinuation of the medication was more frequent in the late older subjects and was for the following reasons: Early; vomiting (3 mg, n = 1) and anorexia (3 mg, n = 1); Late; vomiting (3 mg, n = 1; 7 mg, n = 1) and anorexia (7 mg, n = 1; 14 mg, n = 1). Most of the other adverse events that were reported were gastrointestinal symptoms, and none of the subjects experienced hypoglycemia.

Outcome measures

Oral semaglutide significantly decreased HbA1c and body weight during the 6-month study period. In addition, the change in HbA1c during the 6-month period correlated with the baseline HbA1c value and the insulin secretory capacity.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2022

Year

05

Month

10

Day

Date of IRB

2022

Year

05

Month

10

Day

Anticipated trial start date

2022

Year

05

Month

10

Day

Last follow-up date

2023

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

We investigate therapeutic effects of oral semaglutide in older patients with type 2 diabetes.

Registered date

2022

Year

08

Month

29

Day

Last modified on

2026

Year

03

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055578