Brief Summary

This trial is conducted in Asia. The aim of this trial is to investigate the dose-response relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide versus placebo as monotherapy on glycaemic control in Japanese subjects with type 2 diabetes mellitus

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

243

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Jan 2017

Typical duration for phase_3 diabetes

Geographic Reach

1 country

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

January 6, 2017

Completed

4 days until next milestone

Study Start

First participant enrolled

January 10, 2017

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2018

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

December 30, 2019

Completed

Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

January 6, 2017

Results QC Date

October 15, 2019

Last Update Submit

January 14, 2021

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c (Week 26)
Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. The endpoint was also evaluated based on data from the in-trial observation period. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Week 0, week 26

Secondary Outcomes (49)

Change in HbA1c (Week 52)
Week 0, week 52
Change in Body Weight (kg)
Week 0, week 26, week 52
Change in Fasting Plasma Glucose
Week 0, week 26, week 52
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile
Week 0, week 26, week 52
Change in Mean Postprandial Increment Over All Meals in SMPG
Week 0, week 26 and week 52
+44 more secondary outcomes

Study Arms (5)

Oral semaglutide 3 mg

EXPERIMENTAL

Drug: Semaglutide

Oral semaglutide 7 mg

EXPERIMENTAL

Drug: Semaglutide

Oral semaglutide 14 mg

EXPERIMENTAL

Drug: Semaglutide

Oral placebo

PLACEBO COMPARATOR

Drug: Placebo

Liraglutide 0.9 mg

ACTIVE COMPARATOR

Drug: Liraglutide

Interventions

SemaglutideDRUG

Oral administration once daily

Oral semaglutide 14 mgOral semaglutide 3 mgOral semaglutide 7 mg

PlaceboDRUG

Oral administration once daily

Oral placebo

LiraglutideDRUG

Subcutaneous (s.c., under the skin) injection once daily

Liraglutide 0.9 mg

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Japanese male or female, age above or equal to 20 years at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus for at least 30 days prior to day of screening
HbA1c 6.5%-9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug as monotherapy and 7.0%-10.0% (53-86 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy alone
Treatment for at least 30 days prior to day of screening with;- stable daily dose of oral anti-diabetic drug as monotherapy (allowed oral anti-diabetic drugs are: metformin, sulphonylurea, glinide, α-glucosidase inhibitor, dipeptidyl peptidase-4 inhibitor and sodium-glucose cotransporter-2 inhibitor) at a half-maximum approved dose or below according to Japanese labelling in addition to diet and exercise therapy. or - diet and exercise therapy alone

You may not qualify if:

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives
Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
History of pancreatitis (acute or chronic)
History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation
Subject presently classified as being in New York Heart Association (NYHA) Class IV
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL)
Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 30 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
Treatment with once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA), once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor or thiazolidinedione in a period of 90 days before the day of screening
Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
Initiation of anti-diabetic medication between the day of screening and the day of randomisation

Contact the study team to confirm eligibility.