Brief Summary

This trial is conducted globally. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide versus Empagliflozin in Subjects with Type 2 Diabetes Mellitus.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

822

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Aug 2016

Typical duration for phase_3 diabetes

Geographic Reach

12 countries

106 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

1.6 years study duration

First Submitted

Initial submission to the registry

August 8, 2016

Completed

2 days until next milestone

Study Start

First participant enrolled

August 10, 2016

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2018

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

December 24, 2019

Completed

Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

August 8, 2016

Results QC Date

October 15, 2019

Last Update Submit

July 11, 2022

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period which was the 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. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Week 0, week 26

Secondary Outcomes (49)

Change in Body Weight (Kg)
Week 0, week 26
Change in HbA1c (%)
Week 0, week 52
Change in Body Weight (kg)
Week 0, week 52
Change in Fasting Plasma Glucose
Week 0, week 26, week 52
Change in SMPG : Mean of the 7-point Profile
Week 0, week 26 and week 52
+44 more secondary outcomes

Study Arms (2)

14 mg oral semaglutide

EXPERIMENTAL

Drug: semaglutide

25 mg empagliflozin

ACTIVE COMPARATOR

Drug: empagliflozin

Interventions

semaglutideDRUG

Oral administration once-daily.

14 mg oral semaglutide

empagliflozinDRUG

Oral administration once-daily.

25 mg empagliflozin

Eligibility Criteria

Age18 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
Male or female, age above or equal to 18 years at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening
HbA1c (glycosylated haemoglobin) of 7.0-10.5 % (53-91 mmol/mol) (both inclusive)
Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose as documented in the subject medical record) at least 90 days prior to the day of screening

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 measure as required by local regulation or practice).For certain specific countries: Additional specific requirements apply
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 or Medullary Thyroid Carcinoma
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 within the past 180 days prior to the day of screening
Subjects presently classified as being in New York Heart Association Class IV
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Subjects with ALT (alanine aminotransferase) above 2.5 x upper normal limit
Renal impairment defined as Estimated Glomerular Filtration Rate below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
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 carcinoma in situ)
History of diabetic ketoacidosis

Contact the study team to confirm eligibility.