Brief Summary

This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic drug) in Japanese subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

458

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Jan 2017

Typical duration for phase_3 diabetes

Geographic Reach

1 country

34 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

January 6, 2017

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed

1 day until next milestone

Study Start

First participant enrolled

January 10, 2017

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2018

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

December 30, 2019

Completed

Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

January 6, 2017

Results QC Date

October 15, 2019

Last Update Submit

February 11, 2021

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Number of Treatment-emergent Adverse Events (TEAEs)
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Weeks 0-57

Secondary Outcomes (32)

Change in HbA1c
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 Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals
Week 0, week 26, week 52
Change in Body Weight (kg)
Week 0, week 26, week 52
+27 more secondary outcomes

Study Arms (4)

Oral semaglutide 3 mg

EXPERIMENTAL

Drug: Semaglutide

Oral semaglutide 7 mg

EXPERIMENTAL

Drug: Semaglutide

Oral semaglutide 14 mg

EXPERIMENTAL

Drug: Semaglutide

Dulaglutide 0.75 mg

ACTIVE COMPARATOR

Drug: Dulaglutide

Interventions

SemaglutideDRUG

Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).

Oral semaglutide 14 mgOral semaglutide 3 mgOral semaglutide 7 mg

DulaglutideDRUG

Subcutaneously administration (s.c., under the skin) once-weekly, as add-on to pre-trial oral antidiabetic drug (OAD).

Dulaglutide 0.75 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 60 days prior to day of screening
HbA1c (glycosylated haemoglobin) between 7.0%-10.5% (53-91 mmol/mol) (both inclusive)
OAD (oral antidiabetic drug) monotherapy with stable daily dose for at least 60 days prior to the day of screening of one of SU (sulphonylurea) glinide , TZD (thiazolidinedione), α-GI (alpha-glucosidase inhibitor) or SGLT-2 (sodium-glucose cotransporter-2) inhibitor according to Japanese labelling

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 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 (TIA) within the past 180 days prior to the day of screening and randomisation
Subjects 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 agonists (GLP-1 RA) or once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor in a period of 90 days before the day of screening
For subjects treated with an OAD other than TZD at screening: Treatment with TZD in a period of 90 days before the day of screening
Treatment with any medication for the indication of diabetes or obesity in addition to background OAD medication (SU, glinide, TZD, α-GI or SGLT-2 inhibitor) in a period of 60 days before the day of screening with the exception of short-term insulin treatment for acute illness for a total of at least 14 days
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)
+1 more criteria

Contact the study team to confirm eligibility.